Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients

NCT04132206 | Recruiting

• 1 other identifier: 18-30
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Differences on gut microbiota composition (bacterial populations) of ScS overtime, at different taxonomic levels (from phyla to species if technique allows) versus healthy controls.

  The patient participation at the study will last 7 months, but healthy volunteers will provide stool sample only once at study entry and won't be followed after that.

  7 months

Study Arms (2)

ScS patients

Patients will provide two stool samples: one collected the day of inclusion and a second, six months later

Other: stool sampling

Healthy subjects

Healthy subjects will provide one stool sample at inclusion.

Other: stool sampling

Interventions

stool sampling OTHER

Participants will provide two stool samples: one collected the day of inclusion and a second, six months later

Healthy subjects; ScS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ScS according to ACR criteria,and healthy volunteers without diagnosis of ScS or any other chronic disease

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:

• \. 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.

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

Hôpital Européen Marseille

Marseille, 13003, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A biological collection called "MEDIBIOTE 2" will be set up in parallel for all the participants in this study, This will be managed by the CRB-HE biobank. It will consist on stool-derived samples (DNA).

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Chloé STAVRIS, MD

  Hôpital Européen Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eya TOUMI, PhD student

CONTACT

04 13 42 81 50; e.toumi@alphabio.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 18, 2019
• Study Start: October 8, 2019
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): June 3, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

FR (1)