Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
Recruiting now
Conditions studied: Systemic Sclerosis
In brief
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.
Key facts
- Study ID
- NCT04132206
- Run by
- Hôpital Européen Marseille
- People needed
- 60
- Starts
- 2019-10-08
- Expected to finish
- 2026-06-03
- Last updated by the study team
- 2025-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- For ScS patients:
- Patients with ScS according to ACR criteria.
- Patients over 18 years old.
- Patients who have signed the consent to participate in this study.
- For control subjects:
- Persons without diagnosis of ScS or any other chronic disease.
- Persons over 18 years old.
- Persons who have signed the consent to participate in this study
You may not qualify if…
- 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.
- Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling.
- 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 is running
- Hôpital Européen Marseille — Marseille, France (enrolling)
Full record on ClinicalTrials.gov
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