Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER). (micSPIDER)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Diseases; Inflammatory Bowel Diseases; Dermatitis; Crohn's Disease

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 82

Contacts and Locations

• Study Contact: Name: Catherine DUNYACH-REMY, Dr.; Phone Number: +334.66.68.32.02; Email: catherine.remy@chu-nimes.fr
• Study Contact Backup: Name: Anissa MEGZARI; Phone Number: +334.66.68.42.36; Email: drc@chu-nimes.fr

Study Locations

• France
  • Aveyron
    • Millau, Aveyron, France, 12100
      • Centre Hospitalier de MILLAU
      • Contact: Ariane FIZAZI, Dr.; Email: a-fizazi@chu-montpellier.fr
      • Principal Investigator: Ariane FIZAZI, Dr.
  • Gard
    • Nîmes, Gard, France, 30029
      • Nîmes University Hospital
      • Contact: Catherine DUNYACH-REMY, Dr.; Phone Number: +334.66.68.32.02; Email: catherine.remy@chu-nimes.fr
      • Principal Investigator: Natacha CATTEAU, Dr.
      • Sub-Investigator: Blanche BERGERET, Dr.
      • Sub-Investigator: Ludovic CAILLO, Dr.
      • Sub-Investigator: Myriam MARQUE, Dr.
  • Hérault
    • Béziers, Hérault, France, 34500
      • CHU de Béziers
      • Contact: Louise GUILLON, Dr.
      • Principal Investigator: Louise GUILLON, Dr.
      • Sub-Investigator: Mohamed BEJAOUI, Dr.
    • Montpellier, Hérault, France, 34090
      • CHU de Montpellier, Hôpital Arnaud de Villeneuve
      • Contact: Grégoire LAVAUD, Dr.; Email: gregoire.lavaud@chu-montpellier.fr
      • Principal Investigator: Grégoire LAVAUD, Dr.
      • Sub-Investigator: Yasmine JERIDI, Dr.
      • Sub-Investigator: Margot MIGNOT, Dr.
      • Sub-Investigator: Laura KOLLEN, Dr.
    • Montpellier, Hérault, France, 34090
      • Montpellier University Hospital, Saint Eloi
      • Sub-Investigator: Romain ALTWEGG
      • Contact: Aurélie DU THANH, Pr.; Email: a-du_thanh@chu-montpellier.fr
      • Principal Investigator: Aurélie DU THANH
      • Sub-Investigator: Anne BOZON
      • Sub-Investigator: Lucile BOIVINEAU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative abundance of S. aureus in the SPIDER+ group	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	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	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	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score	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	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	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	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)	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)	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)	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	Yes/No	Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds	Yes/No	Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds	Yes/No	Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils	Yes/No	Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils	Yes/No	Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils	Yes/No	Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel	Yes/No	Month 0, baseline
Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel	Yes/No	Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel	Yes/No	Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears	Yes/No	Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears	Yes/No	Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears	Yes/No	Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek	Yes/No	Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek	Yes/No	Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek	In %	Month 12
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Measured in %	Month 12
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites	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	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	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	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	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	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	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	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	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	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	Real-time monitoring using the Quantum automat, in %	Month 0 to Month 12
Biofilm formation of S. aureus strains isolated from SPIDER+ lesion sites	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	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	Number of samples	Month 0, baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of patients	The age of patients will be recorded in years	Month 0, baseline
Weight of patients	The weight of patients will be recorded in kilograms	Month 0, baseline
Height of patients	The height of patients will be recorded in centimeters	Month 0, baseline
Sex of patients	Male/Female/Non-binary	Month 0, baseline
Active smoker	YES/NO	Month 0, baseline
Severity and duration of Inflammatory Bowel Disease : Mayo Endoscopic Score	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	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	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.	All treatments prior to initiation of anti-TNFα therapy, the duration of anti-TNFα therapy and concomitant treatments will be recorded.	Month 0, baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: August 26, 2026
• First Submitted That Met QC Criteria: September 4, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; Inflammatory Bowel Diseases; anti-TNFα therapies
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin and Connective Tissue Diseases; Staphylococcal Infections; Dermatitis; Crohn Disease; Inflammatory Bowel Diseases; Skin Diseases
• Other Study ID Numbers: AOI2024/2025/CDR-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No