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Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients

Study acronym: ScleroBiotique
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Oct 8, 2023 to Jun 3, 2026
    • Study completion date: Apr 8, 2024 to Jun 3, 2026
    v4
  2. Study sites: 2 to 1v3
  3. Primary completion date: Oct 8, 2022 to Oct 8, 2023
    • Study completion date: Apr 8, 2023 to Apr 8, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04132206
Lead Sponsor Hôpital Européen Marseille
Conditions
(from sponsor)		 Systemic Sclerosis
Related terms Scleroderma, Systemic
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov