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. září 2026 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Zatím nenabíráme
Podmínky
Podmínky
Detailní popis
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).
Typ studie
Typ studie
Pozorovací
Zápis (Odhadovaný)
Zápis
82
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Catherine DUNYACH-REMY, Dr.
- Telefonní číslo: +334.66.68.32.02
- E-mail: catherine.remy@chu-nimes.fr
Studijní záloha kontaktů
- Jméno: Anissa MEGZARI
- Telefonní číslo: +334.66.68.42.36
- E-mail: drc@chu-nimes.fr
Studijní místa
-
-
Aveyron
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Millau, Aveyron, Francie, 12100
- Centre Hospitalier de MILLAU
-
Kontakt:
- Ariane FIZAZI, Dr.
- E-mail: a-fizazi@chu-montpellier.fr
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Vrchní vyšetřovatel:
- Ariane FIZAZI, Dr.
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Gard
-
Nîmes, Gard, Francie, 30029
- Nîmes University Hospital
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Kontakt:
- Catherine DUNYACH-REMY, Dr.
- Telefonní číslo: +334.66.68.32.02
- E-mail: catherine.remy@chu-nimes.fr
-
Vrchní vyšetřovatel:
- Natacha CATTEAU, Dr.
-
Dílčí vyšetřovatel:
- Blanche BERGERET, Dr.
-
Dílčí vyšetřovatel:
- Ludovic CAILLO, Dr.
-
Dílčí vyšetřovatel:
- Myriam MARQUE, Dr.
-
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Hérault
-
Béziers, Hérault, Francie, 34500
- CHU de Béziers
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Kontakt:
- Louise GUILLON, Dr.
-
Vrchní vyšetřovatel:
- Louise GUILLON, Dr.
-
Dílčí vyšetřovatel:
- Mohamed BEJAOUI, Dr.
-
Montpellier, Hérault, Francie, 34090
- CHU de Montpellier, Hôpital Arnaud de Villeneuve
-
Kontakt:
- Grégoire LAVAUD, Dr.
- E-mail: gregoire.lavaud@chu-montpellier.fr
-
Vrchní vyšetřovatel:
- Grégoire LAVAUD, Dr.
-
Dílčí vyšetřovatel:
- Yasmine JERIDI, Dr.
-
Dílčí vyšetřovatel:
- Margot MIGNOT, Dr.
-
Dílčí vyšetřovatel:
- Laura KOLLEN, Dr.
-
Montpellier, Hérault, Francie, 34090
- Montpellier University Hospital, Saint Eloi
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Dílčí vyšetřovatel:
- Romain ALTWEGG
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Kontakt:
- Aurélie DU THANH, Pr.
- E-mail: a-du_thanh@chu-montpellier.fr
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Vrchní vyšetřovatel:
- Aurélie DU THANH
-
Dílčí vyšetřovatel:
- Anne BOZON
-
Dílčí vyšetřovatel:
- Lucile BOIVINEAU
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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)
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Počet skupin / kohort
2
Kohorty a intervence
Skupina / kohortaSkupina / kohorta |
|---|
|
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)
|
|
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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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Relative abundance of S. aureus in the SPIDER+ group
Časové okno: Month 0, baseline
|
Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from SPIDER lesions
|
Month 0, baseline
|
|
Relative abundance of S. aureus in the control group
Časové okno: 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
|
Month 0, baseline
|
|
Relative abundance of S. aureus in the SPIDER+ group
Časové okno: 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
|
Month 6
|
|
Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
|
Relative abundance of species found in the experimental group (SPIDER+ patients)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Časové okno: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Časové okno: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Časové okno: Month 12
|
Yes/No
|
Month 12
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Časové okno: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Časové okno: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Časové okno: Month 12
|
Yes/No
|
Month 12
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Časové okno: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Časové okno: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Časové okno: Month 12
|
Yes/No
|
Month 12
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Časové okno: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Časové okno: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Časové okno: Month 12
|
Yes/No
|
Month 12
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Časové okno: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Časové okno: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Časové okno: Month 12
|
In %
|
Month 12
|
|
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Month 12
|
Measured in %
|
Month 12
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Month 0, baseline
|
Number of samples
|
Month 0, baseline
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Age of patients
Časové okno: Month 0, baseline
|
The age of patients will be recorded in years
|
Month 0, baseline
|
|
Weight of patients
Časové okno: Month 0, baseline
|
The weight of patients will be recorded in kilograms
|
Month 0, baseline
|
|
Height of patients
Časové okno: Month 0, baseline
|
The height of patients will be recorded in centimeters
|
Month 0, baseline
|
|
Sex of patients
Časové okno: Month 0, baseline
|
Male/Female/Non-binary
|
Month 0, baseline
|
|
Active smoker
Časové okno: Month 0, baseline
|
YES/NO
|
Month 0, baseline
|
|
Severity and duration of Inflammatory Bowel Disease : Mayo Endoscopic Score
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
1. září 2026
Primární dokončení (Odhadovaný)
Primární dokončení
1. září 2028
Dokončení studie (Odhadovaný)
Dokončení studie
1. září 2029
Termíny zápisu do studia
První předloženo
První předloženo
26. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
4. září 2026
První zveřejněno (Aktuální)
První zveřejněno
10. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
10. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. září 2026
Naposledy ověřeno
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Střevní nemoci
- Infekce
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Gastroenteritida
- Gram-pozitivní bakteriální infekce
- Bakteriální infekce
- Bakteriální infekce a mykózy
- Onemocnění kůže a pojivové tkáně
- Stafylokokové infekce
- Dermatitida
- Crohnova nemoc
- Zánětlivá onemocnění střev
- Kožní choroby
Další identifikační čísla studie
Další identifikační čísla studie
- AOI2024/2025/CDR-01
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .