NCT04132206Recruiting
Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
ScleroBiotique: Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 8 Oct 2019
- Start date
- 8 Oct 2019
- Primary completion date
- 3 Jun 2026
- Lead sponsor
- Hôpital Européen Marseille
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT04132206
What you commit to
- Study type: Observational
- Planned participants: 60
- From 8 Oct 2019 to the primary completion date, 3 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Persons undergoing psychiatric follow-up.
Lab values
- 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 :
Age
- Persons of full-age who are subject to a legal protection measure or who are unable to express their consent.
Other
- Pregnant, women in labour and breastfeeding mothers.
- Persons deprived of their liberty by a judicial or administrative decision.
- Minors
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.