Gut microbiome changes over six months in adults with systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.