Informations générales (source: ClinicalTrials.gov)
ScleroBiotique: Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients (ScleroBiotique)
Observational
Hôpital Européen Marseille (Voir sur ClinicalTrials)
octobre 2019
avril 2024
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Européen Marseille - 13003 - Marseille - France | Chloé STAVRIS, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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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.