Gut microbiome changes over six months in adults with systemic sclerosis
ScleroBiotique: Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
This project will test whether gut bacteria patterns differ over six months between adults with systemic sclerosis and healthy adults matched by age and sex.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpital Européen Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT04132206 on ClinicalTrials.gov |
What this trial studies
This single-center prospective study in Marseille compares the intestinal microbiota of adults with systemic sclerosis to age- and sex-matched healthy controls. Participants provide stool samples at enrollment and again six months later, alongside clinical and dietary interviews and biological characterization for patients. Microbial DNA will be sequenced and analyzed with DADA2 and Kraken, and discriminant signatures will be sought using LEfSe linear discriminant analysis. The primary aim is to identify microbial patterns that are consistently different in systemic sclerosis patients over time.
Who should consider this trial
Good fit: Adults (age ≥18) who meet ACR criteria for systemic sclerosis and can consent and provide stool samples, plus healthy adult controls without chronic disease, are eligible.
Not a fit: People recently treated with antibiotics, probiotics, prebiotics or other agents that alter the gut microbiota within two months, pregnant or breastfeeding individuals, those with severe anemia, or those unable to consent may not receive benefit or be ineligible.
Why it matters
Potential benefit: If successful, the project could identify gut microbial signatures that help diagnose or predict disease activity and point to microbiome-based interventions for systemic sclerosis.
How similar studies have performed: Small cross-sectional studies have reported microbiome differences in systemic sclerosis, but longitudinal, well-characterized cohorts remain limited, so this approach is partially supported but still exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For ScS patients: 1. Patients with ScS according to ACR criteria. 2. Patients over 18 years old. 3. Patients who have signed the consent to participate in this study. For control subjects: 1. Persons without diagnosis of ScS or any other chronic disease. 2. Persons over 18 years old. 3. Persons who have signed the consent to participate in this study Exclusion Criteria: * 1\. Persons with severe anemia (Hb \< 7 g/dL). 2. Persons who cannot read French. 3. For control subjects: Persons with a particular symptom (as an example of digestive disorders), or under long-term treatment related to another pathology. 4\. Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling. 5\. Persons referred to the article L1121-5 to 1121-8 of the Public health code, namely : * Pregnant, women in labour and breastfeeding mothers. * Persons deprived of their liberty by a judicial or administrative decision. * Persons undergoing psychiatric follow-up. * Minors * Persons of full-age who are subject to a legal protection measure or who are unable to express their consent.
Where this trial is running
Marseille
- Hôpital Européen Marseille — Marseille, France (Recruiting)
Study contacts
- Principal investigator: Chloé STAVRIS, MD — Hôpital Européen Marseille
- Study coordinator: Eya TOUMI, PhD student
- Email: e.toumi@alphabio.fr
- Phone: 04 13 42 81 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.