Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER). (micSPIDER)
4 сентября 2026 г. обновлено: Centre Hospitalier Universitaire de Nīmes
Inflammatory Skin Diseases of Skin Folds and Perioral Areas (SPIDER) in Patients With Chronic Inflammatory Bowel Disease on Anti-TNFα Therapy: Characterization of the Staphylococcus Aureus Population Within the Lesion Microbiota and Correlation With Clinical Findings
The main objective of this study is to evaluate the change in the relative abundance of S. aureus within the lesion-site skin microbiota in SPIDER patients (change between inclusion and 6 months), and to assess whether this change in S. aureus abundance is associated with a favorable (or unfavorable) evolution of the wounds over the same period.
Обзор исследования
Статус
Еще не набирают
Подробное описание
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), affect around 2.5 million people worldwide, including 300,000 in France. These conditions mainly impact young adults and follow a relapsing-remitting course with significant morbidity. CD is a chronic, debilitating disease caused by complex interactions among genetic, environmental, and microbiota-related factors, leading to transmural inflammation of the digestive tract and both intestinal and extra-intestinal symptoms. UC affects the mucosa of the colon and rectum, with similar gastrointestinal symptoms and frequent cutaneous, ocular, and rheumatologic manifestations.
Treatment aims for deep remission and relies largely on anti-TNFα therapies, complemented by other drugs or surgery; newer biologics like vedolizumab and ustekinumab are also used. However, anti-TNFα-treated patients often develop cutaneous comorbidities, such as psoriasis, granulomatous lesions, or neutrophilic dermatoses. A significant proportion also develop skin infections, commonly due to Staphylococcus aureus. One study reported inflammatory skin lesions in 40% of IBD patients on anti-TNFα, with S. aureus nasal or cutaneous carriage frequently associated. The precise relationship between S. aureus and these lesions, however, remains unclear.
Description of the treatment/strategy/procedure: Swabbing of healthy areas and lesion sites will be performed in the same way in the SPIDER+ and SPIDER- groups at Day 0 (D0). Microbiota sequencing and cultures will be carried out under the same conditions in both groups.
Description of follow-up: SPIDER+ patients will be recruited from the dermatology departments of the participating university hospitals (CHUs), notably in Montpellier, Millau, and Béziers. They will receive follow-up over a 12-month period, with an inclusion visit followed by two follow-up visits at 6 and 12 months. On the other hand, for SPIDER- patients a follow-up visit will take place at 12 months, in order to record adverse effects of the treatment (anti-TNF).
Тип исследования
Наблюдательный
Регистрация (Оцененный)
82
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Catherine DUNYACH-REMY, Dr.
- Номер телефона: +334.66.68.32.02
- Электронная почта: catherine.remy@chu-nimes.fr
Учебное резервное копирование контактов
- Имя: Anissa MEGZARI
- Номер телефона: +334.66.68.42.36
- Электронная почта: drc@chu-nimes.fr
Места учебы
-
-
Aveyron
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Millau, Aveyron, Франция, 12100
- Centre Hospitalier de MILLAU
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Контакт:
- Ariane FIZAZI, Dr.
- Электронная почта: a-fizazi@chu-montpellier.fr
-
Главный следователь:
- Ariane FIZAZI, Dr.
-
-
Gard
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Nîmes, Gard, Франция, 30029
- Nîmes University Hospital
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Контакт:
- Catherine DUNYACH-REMY, Dr.
- Номер телефона: +334.66.68.32.02
- Электронная почта: catherine.remy@chu-nimes.fr
-
Главный следователь:
- Natacha CATTEAU, Dr.
-
Младший исследователь:
- Blanche BERGERET, Dr.
-
Младший исследователь:
- Ludovic CAILLO, Dr.
-
Младший исследователь:
- Myriam MARQUE, Dr.
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Hérault
-
Béziers, Hérault, Франция, 34500
- CHU de Béziers
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Контакт:
- Louise GUILLON, Dr.
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Главный следователь:
- Louise GUILLON, Dr.
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Младший исследователь:
- Mohamed BEJAOUI, Dr.
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Montpellier, Hérault, Франция, 34090
- CHU de Montpellier, Hôpital Arnaud de Villeneuve
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Контакт:
- Grégoire LAVAUD, Dr.
- Электронная почта: gregoire.lavaud@chu-montpellier.fr
-
Главный следователь:
- Grégoire LAVAUD, Dr.
-
Младший исследователь:
- Yasmine JERIDI, Dr.
-
Младший исследователь:
- Margot MIGNOT, Dr.
-
Младший исследователь:
- Laura KOLLEN, Dr.
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Montpellier, Hérault, Франция, 34090
- Montpellier University Hospital, Saint Eloi
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Младший исследователь:
- Romain ALTWEGG
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Контакт:
- Aurélie DU THANH, Pr.
- Электронная почта: a-du_thanh@chu-montpellier.fr
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Главный следователь:
- Aurélie DU THANH
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Младший исследователь:
- Anne BOZON
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Младший исследователь:
- Lucile BOIVINEAU
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
Adult or pediatric patient (>4 years old), diagnosed with IBD and receiving anti-TNFα therapy, with skin lesions such as crusted rhinitis ± inflammatory alopecic scalp lesions ± intertrigo of the large skin folds ± folliculitis (Scalp and Periorificial Inflammatory DERmatis, SPIDER)
Описание
Inclusion Criteria:
- Diagnosed with IBD
- Receiving anti-TNFα therapy
- WITH skin lesions such as crusted rhinitis ± inflammatory alopecic scalp lesions ± intertrigo of the large skin folds ± folliculitis (Scalp and Periorificial Inflammatory DERmatis, SPIDER)
- Parental consent for minor patients
- Patient who has provided free and informed consent and has signed the consent form
- Patient affiliated to or beneficiary of a health insurance system
Exclusion Criteria:
- Patients for whom a change in therapy is planned within 6 months (SPIDER+).
- Patients receiving antibiotics (systemic or topical) at the time of enrollment, with a window of at least 1 month.
- Patients who have participated in a clinical drug trial within the last three months
- Patients currently in an exclusion period determined by a previous study
- Patients under legal guardianship, conservatorship, or trusteeship
- Patients who refuse to sign the informed consent form
- Pregnant or breastfeeding patients.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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SPIDER+ group
Patients diagnosed with IBD receiving anti-TNFα therapy with skin lesions such as crusted rhinitis ± inflammatory alopecic scalp lesions ± intertrigo of the large skin folds ± folliculitis (Scalp and Periorificial Inflammatory DERmatis, SPIDER)
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SPIDER- group (control group):
Patients diagnosed with IBD receiving anti-TNFα therapy for more than 1 year, WITHOUT dermatological lesions suggestive of SPIDER
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Relative abundance of S. aureus in the SPIDER+ group
Временное ограничение: Month 0, baseline
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Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from SPIDER lesions
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Month 0, baseline
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Relative abundance of S. aureus in the control group
Временное ограничение: Month 0, baseline
|
Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from healthy areas
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Month 0, baseline
|
|
Relative abundance of S. aureus in the SPIDER+ group
Временное ограничение: Month 6
|
Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from SPIDER lesions
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Month 6
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Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group
Временное ограничение: Month 0, baseline
|
The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator). The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score. The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score. |
Month 0, baseline
|
|
Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group
Временное ограничение: Month 6
|
The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator).The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score. The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score. |
Month 6
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Relative abundance of S. aureus according to the Dermatology Quality of Life Index in the SPIDER+ group
Временное ограничение: Month 0, baseline
|
The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life.
It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30.
Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).
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Month 0, baseline
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Relative abundance of S. aureus according to the Dermatology Quality of Life Index in the SPIDER+ group
Временное ограничение: Month 6
|
The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life.
It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30.
Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).
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Month 6
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Временное ограничение: Month 0, baseline
|
The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator). The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score. The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score. |
Month 0, baseline
|
|
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Временное ограничение: Month 12
|
The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator). The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score. The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score. |
Month 12
|
|
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index
Временное ограничение: Month 0, baseline
|
The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life.
It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30.
Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).
|
Month 0, baseline
|
|
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index
Временное ограничение: Month 12
|
The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life.
It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30.
Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).
|
Month 12
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Relative abundance of species found in the experimental group (SPIDER+ patients)
Временное ограничение: Month 0, baseline
|
Relative abundances (in %) of each bacterial species, calculation of alpha diversity (Shannon index) and beta diversity (Bray-Curtis index) following sequencing of swabs taken from lesions at M0, M6, and M12 in SPIDER+ patients.
|
Month 0, baseline
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|
Relative abundance of species found in the experimental group (SPIDER+ patients)
Временное ограничение: Month 6
|
Relative abundances (in %) of each bacterial species, calculation of alpha diversity (Shannon index) and beta diversity (Bray-Curtis index) following sequencing of swabs taken from lesions at M0, M6, and M12 in SPIDER+ patients.
|
Month 6
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|
Relative abundance of species found in the experimental group (SPIDER+ patients)
Временное ограничение: Month 12
|
Relative abundances (in %) of each bacterial species, calculation of alpha diversity (Shannon index) and beta diversity (Bray-Curtis index) following sequencing of swabs taken from lesions at M0, M6, and M12 in SPIDER+ patients.
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Month 12
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Временное ограничение: Month 0, baseline
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Yes/No
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Month 0, baseline
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Временное ограничение: Month 6
|
Yes/No
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Month 6
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Временное ограничение: Month 12
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Yes/No
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Month 12
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Временное ограничение: Month 0, baseline
|
Yes/No
|
Month 0, baseline
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Временное ограничение: Month 6
|
Yes/No
|
Month 6
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Временное ограничение: Month 12
|
Yes/No
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Month 12
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Временное ограничение: Month 0, baseline
|
Yes/No
|
Month 0, baseline
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Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Временное ограничение: Month 6
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Yes/No
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Month 6
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Временное ограничение: Month 12
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Yes/No
|
Month 12
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Временное ограничение: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Временное ограничение: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Временное ограничение: Month 12
|
Yes/No
|
Month 12
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Временное ограничение: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Временное ограничение: Month 6
|
Yes/No
|
Month 6
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|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Временное ограничение: Month 12
|
In %
|
Month 12
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Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Временное ограничение: Month 6
|
A "favorable" change in the lesion at Month12 will be defined as: a decrease of at least 2 points in the Physician's Global Assessment score (0-5, wherein 0 indicates improvement and 5 indicates worsening) compared to M0, or a Physician's Global Assessment score of 1 or less. |
Month 6
|
|
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Временное ограничение: Month 12
|
A "favorable" change in the lesion at Month12 will be defined as: a decrease of at least 2 points in the Physician's Global Assessment score (0-5, wherein 0 indicates improvement and 5 indicates worsening) compared to Month 0, or a Physician's Global Assessment score of 1 or less. |
Month 12
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Evolution of lesions according to the Dermatology Live Quality Index in SPIDER+ patients
Временное ограничение: Month 6
|
A "favorable" change in the lesion at Month12 will be defined as: an optimal target of up to 5 points or a reduction of at least 4 points compared to Month 0.
|
Month 6
|
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Evolution of lesions according to the Dermatology Live Quality Index in SPIDER+ patients
Временное ограничение: Month 12
|
A "favorable" change in the lesion at Month12 will be defined as: an optimal target of up to 5 points or a reduction of at least 4 points compared to Month 0.
|
Month 12
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Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Временное ограничение: Month 0, baseline
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
|
Month 0, baseline
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Временное ограничение: Month 6
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
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Month 6
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Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Временное ограничение: Month 12
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
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Month 12
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Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Временное ограничение: Month 0, baseline
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
|
Month 0, baseline
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|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Временное ограничение: Month 6
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
|
Month 6
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Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Временное ограничение: Month 12
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
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Month 12
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Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Временное ограничение: Month 0, baseline
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
|
Month 0, baseline
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Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Временное ограничение: Month 6
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
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Month 6
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Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Временное ограничение: Month 12
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
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Month 12
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Временное ограничение: Month 0, baseline
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
|
Month 0, baseline
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Временное ограничение: Month 6
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
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Month 6
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Временное ограничение: Month 12
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
|
Month 12
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Временное ограничение: Month 0, baseline
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
|
Month 0, baseline
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Временное ограничение: Month 6
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
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Month 6
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Временное ограничение: Month 12
|
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
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Month 12
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Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients
Временное ограничение: Month 0, baseline
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Relative abundances (in %) of each bacterial species, including S. aureus following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
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Month 0, baseline
|
|
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients: Alpha diversity
Временное ограничение: Month 0, baseline
|
Calculation of alpha diversity (Shannon index) following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
|
Month 0, baseline
|
|
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients: Beta diversity
Временное ограничение: Month 0, baseline
|
Calculation of beta diversity (Bray-Curtis index) following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
|
Month 0, baseline
|
|
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER - patients
Временное ограничение: Month 0, baseline
|
Relative abundances (in %) of each bacterial species, including S. aureus following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
|
Month 0, baseline
|
|
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER - patients: Alpha diversity
Временное ограничение: Month 0, baseline
|
Calculation of alpha diversity (Shannon index) following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
|
Month 0, baseline
|
|
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER - patients: beta diversity
Временное ограничение: Month 0, baseline
|
Calculation of beta diversity (Bray-Curtis index) following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
|
Month 0, baseline
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: length
Временное ограничение: Month 0, baseline
|
Measured in Mb
|
Month 0, baseline
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: length
Временное ограничение: Month 6
|
Measured in Mb
|
Month 6
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: length
Временное ограничение: Month 12
|
Measured in Mb
|
Month 12
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: guanine-cytosine content
Временное ограничение: Month 0, baseline
|
Measured in %
|
Month 0, baseline
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: guanine-cytosine content
Временное ограничение: Month 6
|
Measured in %
|
Month 6
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: guanine-cytosine content
Временное ограничение: Month 12
|
Measured in %
|
Month 12
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: presence of plasmids
Временное ограничение: Month 0, baseline
|
YES / NO
|
Month 0, baseline
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: presence of plasmids
Временное ограничение: Month 6
|
YES / NO
|
Month 6
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: presence of plasmids
Временное ограничение: Month 12
|
YES / NO
|
Month 12
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: genome alignment
Временное ограничение: Month 0, baseline
|
Measured in %
|
Month 0, baseline
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: genome alignment
Временное ограничение: Month 6
|
Measured in %
|
Month 6
|
|
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: genome alignment
Временное ограничение: Month 12
|
Measured in %
|
Month 12
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Временное ограничение: Month 0, baseline
|
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
|
Month 0, baseline
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Временное ограничение: Month 6
|
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
|
Month 6
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Временное ограничение: Month 12
|
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
|
Month 12
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from healthy areas in SPIDER+ patients
Временное ограничение: Month 0, baseline
|
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
|
Month 0, baseline
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from healthy areas in SPIDER+ patients
Временное ограничение: Month 6
|
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
|
Month 6
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from healthy areas in SPIDER+ patients
Временное ограничение: Month 12
|
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
|
Month 12
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from staphylococcal reservoirs
Временное ограничение: Month 0, baseline
|
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
|
Month 0, baseline
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from staphylococcal reservoirs
Временное ограничение: Month 6
|
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
|
Month 6
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from staphylococcal reservoirs
Временное ограничение: Month 12
|
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
|
Month 12
|
|
Real-time monitoring of the growth of S. aureus strains isolated from SPIDER+ lesion sites
Временное ограничение: Month 0 to Month 12
|
Real-time monitoring using the Quantum automat, in %
|
Month 0 to Month 12
|
|
Real-time monitoring of the growth of S. aureus strains isolated from apparently healthy areas in SPIDER+ patients
Временное ограничение: Month 0 to Month 12
|
Real-time monitoring using the Quantum automat, in %
|
Month 0 to Month 12
|
|
Biofilm formation of S. aureus strains isolated from SPIDER+ lesion sites
Временное ограничение: Month 0 to Month 12
|
Growth curves using the Bioflux automat
|
Month 0 to Month 12
|
|
Biofilm formation of S. aureus strains isolated from apparently healthy areas in SPIDER+ patients
Временное ограничение: Month 0 to Month 12
|
Growth curves using the Bioflux automat
|
Month 0 to Month 12
|
|
Constitution of a biobank of samples taken by swabbing of lesion sites in SPIDER+ patients
Временное ограничение: Month 0, baseline
|
Number of samples
|
Month 0, baseline
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Age of patients
Временное ограничение: Month 0, baseline
|
The age of patients will be recorded in years
|
Month 0, baseline
|
|
Weight of patients
Временное ограничение: Month 0, baseline
|
The weight of patients will be recorded in kilograms
|
Month 0, baseline
|
|
Height of patients
Временное ограничение: Month 0, baseline
|
The height of patients will be recorded in centimeters
|
Month 0, baseline
|
|
Sex of patients
Временное ограничение: Month 0, baseline
|
Male/Female/Non-binary
|
Month 0, baseline
|
|
Active smoker
Временное ограничение: Month 0, baseline
|
YES/NO
|
Month 0, baseline
|
|
Severity and duration of Inflammatory Bowel Disease : Mayo Endoscopic Score
Временное ограничение: Month 0, baseline
|
The severity and duration of Inflammatory Bowel Disease will be recorded according to the Mayo Endoscopic Score.
The Mayo Endoscopic Score is a 0 to 4 grading system (scored 0 to 3) used during a colonoscopy to assess the severity of inflammation in patients with ulcerative colitis based on the most involved area of the colon.
|
Month 0, baseline
|
|
The severity and duration of Inflammatory Bowel Disease according to the Harvey-Bradshaw Score
Временное ограничение: Month 0, baseline
|
The severity and duration of Inflammatory Bowel Disease will be recorded according to the Harvey-Bradshaw Score. The Harvey-Bradshaw Index (HBI) is a simplified clinical questionnaire used to quantify the severity and monitor the progression of Crohn's disease. Developed in 1980, it serves as a streamlined alternative to the more complex Crohn's Disease Activity Index, relying primarily on symptoms from the previous day as follows: General Well-Being:0: Very well1, Slightly below par 2, Poor 3, Very poor 4, Terrible Abdominal Pain:0, None1, Mild 2, Moderate 3, Severe Liquid Stools,1 point per bowel movement (Recorded for the previous day). Abdominal Mass:0, None1, Dubious 2, Definite 3, Definite and tender Complications (Score 1 point for each present condition). Joint pain (Arthralgia), Eye inflammation (Uveitis) Red, tender skin nodules (Erythema nodosum), Mouth ulcers (Aphthous ulcers), Necrotic skin ulcers (Pyoderma gangrenosum) Anal fissure, Fistula, Abscess. |
Month 0, baseline
|
|
Montreal Inflammatory Bowel Disease Classification
Временное ограничение: Month 0, baseline
|
The Montreal Inflammatory Bowel Disease Classification is the gold-standard for classifying Crohn's Disease and Ulcerative Colitis.
Crohn's disease has 3 distinct variables (Age, Location, and Behavior):Age at Diagnosis (A):A1: ≤ 16 years, A2: 17 to 40 years, A3: > 40 years.
Location (L):L1: Ileal (terminal ileum)L2: Colonic (large intestine)L3: Ileocolonic (both small and large intestine)L4: Upper Gastrointestinal tract (can coexist with L1-L3).
Behavior (B):B1: Non-stricturing, non-penetrating (inflammatory phase)B2: Stricturing (narrowing of the bowel) B3: Penetrating (fistulae or abscesses)p: Perianal disease.
Ulcerative Colitis is classified by the extent of anatomical involvement and severity:E1 (Ulcerative Proctitis): Limited strictly to the rectum.E2 (Left-sided UC): Extends up to the splenic flexure.E3 (Extensive/Pancolitis): Extends proximally past the splenic flexure, involving the whole colon.S0-S3 (Severity): Clinical remission (S0) to severe clinical attacks (S3).
|
Month 0, baseline
|
|
Treatments prior to initiation of anti-TNFα therapy, duration of anti-TNFα therapy and concomitant treatments.
Временное ограничение: Month 0, baseline
|
All treatments prior to initiation of anti-TNFα therapy, the duration of anti-TNFα therapy and concomitant treatments will be recorded.
|
Month 0, baseline
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 сентября 2026 г.
Первичное завершение (Оцененный)
1 сентября 2028 г.
Завершение исследования (Оцененный)
1 сентября 2029 г.
Даты регистрации исследования
Первый отправленный
26 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
4 сентября 2026 г.
Первый опубликованный (Действительный)
10 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
10 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
4 сентября 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Кишечные заболевания
- Инфекции
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Гастроэнтерит
- Грамположительные бактериальные инфекции
- Бактериальные инфекции
- Бактериальные инфекции и микозы
- Заболевания кожи и соединительной ткани
- Стафилококковые инфекции
- Дерматит
- Болезнь Крона
- Воспалительные заболевания кишечника
- Кожные заболевания
Другие идентификационные номера исследования
- AOI2024/2025/CDR-01
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .