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Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials

Study acronym: VIOLONSEL
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 52 words
    • Study description shortened, about 11 words
    • Site details revised
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2024 to Jul 8, 2024
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Currently, ANSM recommendations govern FMT (Fecal Microbiota Transplantation) in clinical trials. The collection and validation of these stool donations as part of the trials is complex and not very efficient. It therefore seems essential to identify the limiting factors and the characteristics of Healthy Volunteer Donors to optimize the number of valid stool donations.
Trial Details
NCT Number NCT06478823
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: CRB-SAT BARM APHP.SU, CRSA UMRS 938
Conditions
(from sponsor)		 Gastro-Intestinal Disorder
Related terms Digestive System Diseases
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov