Status:
RECRUITING
Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
Lead Sponsor:
Hôpital Européen Marseille
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Brief 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 t...
Detailed Description
This is an explorative, prospective, monocentric open-label study qualified as interventional researches at minimal risks and constraints (called in French RIPH, category 2). This is a study of the g...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 3 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04132206
Start Date
October 8 2019
End Date
June 3 2026
Last Update
September 25 2025
Active Locations (1)
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1
Hôpital Européen Marseille
Marseille, France, 13003