Tracking gut bacteria over time in people with systemic sclerosis
Studies gut bacteria in adults with systemic sclerosis through repeated stool samples.
Plain-language title generated from the registry record
Registry title: Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
Key facts
- Where
- Marseille, FranceSee the site
Where in France
- Hopital Europeen MarseilleMarseille, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hôpital Européen Marseille
- Trial code
- NCT04132206
- Record updated
- 25 September 2025
- Original description
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.Read full original descriptionShow less
ScleroBiotique: Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
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.
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: Persons undergoing psychiatric follow-up; 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 :; Persons of full-age who are subject to a legal protection measure or who are unable to express their consent; Pregnant, women in labour and breastfeeding mothers; Persons deprived of their liberty by a judicial or administrative decision; Minors.