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Recruiting Observational

Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients

NCT04132206 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2019-10-08
Last updated
2025-09-25

Condition(s) studied

Systemic Sclerosis

Investigational drug(s) / intervention(s)

stool sampling

stool sampling: Participants will provide two stool samples: one collected the day of inclusion and a second, six months later

Study summary

Today, the study of gut microbiota has taken a prominent place in several fields of medical research. Numerous experimental data in humans and animals suggest that an imbalance in the composition of the microbiota could contribute to the pathophysiology of systemic autoimmune diseases such as Systemic Sclerosis (SCS). A future exploration of the microbiota, a source of diagnostic and/or prognostic biomarkers, may be very useful for tomorrow's medicine by proposing therapeutic interventions based on the correction of possible imbalances in the intestinal flora. Studies of the human gut microbiota in patients with ScS are limited to low-impact investigations, due to the lack of data on the clinical and biological characterization of the patients studied, and to the absence of longitudinal studies in the same patient. For this reason, we are interested in exploring the intestinal microbiota of ScS patients in a comprehensive and longitudinal way.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Differences on gut microbiota composition (bacterial populations) of ScS overtime, at different taxonomic levels (from phyla to species if technique allows) versus healthy controls. — 7 months
    The patient participation at the study will last 7 months, but healthy volunteers will provide stool sample only once at study entry and won't be followed after that.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Européen Marseille Marseille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04132206 on ClinicalTrials.gov ↗ ← All trials in France