Clinical Trial

Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients

Study acronym: ScleroBiotique
Recruiting
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Record status
This record was last updated September 25, 2025 (before its estimated June 3, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-10-16; most recent amendment 2025-09-24.
Trial Details
NCT Number NCT04132206
Lead Sponsor Hôpital Européen Marseille
Conditions Systemic Sclerosis
Enrollment 60 participants
Start Date 2019-10-08
Primary Completion 2026-06-03 (estimated)
Study Completion 2026-06-03 (estimated)
Updated on ClinicalTrials.gov 2025-09-25