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 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Descrição detalhada
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).
Tipo de estudo
Observacional
Inscrição (Estimado)
82
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Catherine DUNYACH-REMY, Dr.
- Número de telefone: +334.66.68.32.02
- E-mail: catherine.remy@chu-nimes.fr
Estude backup de contato
- Nome: Anissa MEGZARI
- Número de telefone: +334.66.68.42.36
- E-mail: drc@chu-nimes.fr
Locais de estudo
-
-
Aveyron
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Millau, Aveyron, França, 12100
- Centre Hospitalier de MILLAU
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Contato:
- Ariane FIZAZI, Dr.
- E-mail: a-fizazi@chu-montpellier.fr
-
Investigador principal:
- Ariane FIZAZI, Dr.
-
-
Gard
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Nîmes, Gard, França, 30029
- Nîmes University Hospital
-
Contato:
- Catherine DUNYACH-REMY, Dr.
- Número de telefone: +334.66.68.32.02
- E-mail: catherine.remy@chu-nimes.fr
-
Investigador principal:
- Natacha CATTEAU, Dr.
-
Subinvestigador:
- Blanche BERGERET, Dr.
-
Subinvestigador:
- Ludovic CAILLO, Dr.
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Subinvestigador:
- Myriam MARQUE, Dr.
-
-
Hérault
-
Béziers, Hérault, França, 34500
- CHU de Béziers
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Contato:
- Louise GUILLON, Dr.
-
Investigador principal:
- Louise GUILLON, Dr.
-
Subinvestigador:
- Mohamed BEJAOUI, Dr.
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Montpellier, Hérault, França, 34090
- CHU de Montpellier, Hôpital Arnaud de Villeneuve
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Contato:
- Grégoire LAVAUD, Dr.
- E-mail: gregoire.lavaud@chu-montpellier.fr
-
Investigador principal:
- Grégoire LAVAUD, Dr.
-
Subinvestigador:
- Yasmine JERIDI, Dr.
-
Subinvestigador:
- Margot MIGNOT, Dr.
-
Subinvestigador:
- Laura KOLLEN, Dr.
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Montpellier, Hérault, França, 34090
- Montpellier University Hospital, Saint Eloi
-
Subinvestigador:
- Romain ALTWEGG
-
Contato:
- Aurélie DU THANH, Pr.
- E-mail: a-du_thanh@chu-montpellier.fr
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Investigador principal:
- Aurélie DU THANH
-
Subinvestigador:
- Anne BOZON
-
Subinvestigador:
- Lucile BOIVINEAU
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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)
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Relative abundance of S. aureus in the SPIDER+ group
Prazo: 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
Prazo: 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 healthy areas
|
Month 0, baseline
|
|
Relative abundance of S. aureus in the SPIDER+ group
Prazo: Month 6
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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 6
|
|
Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group
Prazo: 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
Prazo: 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
|
|
Relative abundance of S. aureus according to the Dermatology Quality of Life Index in the SPIDER+ group
Prazo: 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 according to the Dermatology Quality of Life Index in the SPIDER+ group
Prazo: 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).
|
Month 6
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
|
|
Relative abundance of species found in the experimental group (SPIDER+ patients)
Prazo: 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
|
|
Relative abundance of species found in the experimental group (SPIDER+ patients)
Prazo: 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.
|
Month 12
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Prazo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Prazo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Prazo: Month 12
|
Yes/No
|
Month 12
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Prazo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Prazo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Prazo: Month 12
|
Yes/No
|
Month 12
|
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Prazo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Prazo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Prazo: Month 12
|
Yes/No
|
Month 12
|
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Prazo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Prazo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Prazo: Month 12
|
Yes/No
|
Month 12
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Prazo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Prazo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Prazo: Month 12
|
In %
|
Month 12
|
|
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Prazo: 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
Prazo: 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
|
|
Evolution of lesions according to the Dermatology Live Quality Index in SPIDER+ patients
Prazo: 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
|
|
Evolution of lesions according to the Dermatology Live Quality Index in SPIDER+ patients
Prazo: 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
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Prazo: 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
Prazo: 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
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Prazo: 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: nostrils
Prazo: 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: nostrils
Prazo: 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
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Prazo: 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: navel
Prazo: 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: navel
Prazo: 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
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Prazo: 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: ears
Prazo: 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
Prazo: 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
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Prazo: 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
Prazo: 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
Prazo: 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
|
|
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Prazo: 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
|
|
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Month 12
|
Measured in %
|
Month 12
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Month 0, baseline
|
Number of samples
|
Month 0, baseline
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Age of patients
Prazo: Month 0, baseline
|
The age of patients will be recorded in years
|
Month 0, baseline
|
|
Weight of patients
Prazo: Month 0, baseline
|
The weight of patients will be recorded in kilograms
|
Month 0, baseline
|
|
Height of patients
Prazo: Month 0, baseline
|
The height of patients will be recorded in centimeters
|
Month 0, baseline
|
|
Sex of patients
Prazo: Month 0, baseline
|
Male/Female/Non-binary
|
Month 0, baseline
|
|
Active smoker
Prazo: Month 0, baseline
|
YES/NO
|
Month 0, baseline
|
|
Severity and duration of Inflammatory Bowel Disease : Mayo Endoscopic Score
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de setembro de 2028
Conclusão do estudo (Estimado)
1 de setembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
26 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de setembro de 2026
Primeira postagem (Real)
10 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de setembro de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Intestinais
- Infecções
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Gastroenterite
- Infecções por Bactérias Gram-Positivas
- Infecções bacterianas
- Infecções Bacterianas e Micoses
- Doenças da Pele e do Tecido Conjuntivo
- Infecções Estafilocócicas
- Dermatite
- Doença de Crohn
- Doenças Inflamatórias Intestinais
- Doenças de pele
Outros números de identificação do estudo
- AOI2024/2025/CDR-01
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .