Inflammatory Bowel DiseasesmicSPIDERNCT07812675
Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER).
An observational study of Inflammatory Bowel Diseases and Crohn's Disease, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn's Disease, Skin Diseases
- How many people
- 82 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2026to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
CHU de Béziers
Béziers, Hérault, 34500
Louise GUILLON, Dr.
Louise GUILLON, Dr.
Centre Hospitalier de MILLAU
Millau, Aveyron, 12100
Ariane FIZAZI, Dr., a-fizazi@chu-montpellier.fr
Ariane FIZAZI, Dr.
CHU de Montpellier, Hôpital Arnaud de Villeneuve
Montpellier, Hérault, 34090
Grégoire LAVAUD, Dr., gregoire.lavaud@chu-montpellier.fr
Grégoire LAVAUD, Dr.
Montpellier University Hospital, Saint Eloi
Montpellier, Hérault, 34090
Aurélie DU THANH, Pr., a-du_thanh@chu-montpellier.fr
Aurélie DU THANH
Nîmes University Hospital
Nîmes, Gard, 30029
Catherine DUNYACH-REMY, Dr., +334.66.68.32.02, catherine.remy@chu-nimes.fr
Natacha CATTEAU, Dr.
About this study
Official title: 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.
Read the 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).
- Keywords
- anti-TNFα therapies, Inflammatory Bowel Diseases, Staphylococcus aureus
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Skin Diseases, Dermatitis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Month 6
Secondary outcomes (73)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Yes/No
Measured: Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Yes/No
Measured: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Yes/No
Measured: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Yes/No
Measured: Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Yes/No
Measured: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Yes/No
Measured: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Yes/No
Measured: Month 0, baseline
Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Yes/No
Measured: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Yes/No
Measured: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Yes/No
Measured: Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Yes/No
Measured: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Yes/No
Measured: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Yes/No
Measured: Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Yes/No
Measured: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
In %
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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 %
Measured: 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 %
Measured: 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 %
Measured: 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
Measured: 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
Measured: 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
Measured: 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 %
Measured: 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 %
Measured: 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 %
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 %
Measured: 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 %
Measured: Month 0 to Month 12
Biofilm formation of S. aureus strains isolated from SPIDER+ lesion sites
Growth curves using the Bioflux automat
Measured: 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
Measured: Month 0 to Month 12
Constitution of a biobank of samples taken by swabbing of lesion sites in SPIDER+ patients
Number of samples
Measured: Month 0, baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812675
- Sponsor's protocol ID
- AOI2024/2025/CDR-01
- Acronym
- micSPIDER
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07812675
- Acronym / sponsor ID
- micSPIDER / AOI2024/2025/CDR-01
- Keywords
- anti-TNFα therapies, Inflammatory Bowel Diseases, Staphylococcus aureus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relative abundance of S. aureus in the SPIDER+ group
Time frame: 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
Relative abundance of S. aureus in the control group
Time frame: 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
Relative abundance of S. aureus in the SPIDER+ group
Time frame: 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
Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group
Time frame: 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.
Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group
Time frame: 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.
Relative abundance of S. aureus according to the Dermatology Quality of Life Index in the SPIDER+ group
Time frame: 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).
Relative abundance of S. aureus according to the Dermatology Quality of Life Index in the SPIDER+ group
Time frame: 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).
73 secondary outcomes
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Time frame: Month 0, baseline
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Time frame: Month 12
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index
Time frame: Month 0, baseline
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index
Time frame: Month 12
Relative abundance of species found in the experimental group (SPIDER+ patients)
Time frame: Month 0, baseline
Relative abundance of species found in the experimental group (SPIDER+ patients)
Time frame: Month 6
Relative abundance of species found in the experimental group (SPIDER+ patients)
Time frame: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Time frame: Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Time frame: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Time frame: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Time frame: Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Time frame: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Time frame: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Time frame: Month 0, baseline
Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Time frame: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Time frame: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Time frame: Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Time frame: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Time frame: Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Time frame: Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Time frame: Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Time frame: Month 12
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Time frame: Month 6
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Time frame: Month 12
Evolution of lesions according to the Dermatology Live Quality Index in SPIDER+ patients
Time frame: Month 6
Evolution of lesions according to the Dermatology Live Quality Index in SPIDER+ patients
Time frame: Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Time frame: Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Time frame: Month 6
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Time frame: Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Time frame: Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Time frame: Month 6
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Time frame: Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Time frame: Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Time frame: Month 6
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Time frame: Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Time frame: Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Time frame: Month 6
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Time frame: Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Time frame: Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn's Disease, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine DUNYACH-REMY, Dr. (+334.66.68.32.02, catherine.remy@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of S. aureus in the SPIDER+ group (time frame: Month 0, baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.