Healthy Volunteer Stool Donors Aged 18 to 49 for Fecal Microbiota Transplantation Research Studies

What this Trial Is About

Researchers are studying the process of selecting healthy volunteer donors for Fecal Microbiota Transplantation FMT trials to improve the efficiency and effectiveness of stool donation collection and validation. The study focuses on identifying factors that limit donation and describing the clinical characteristics and lifestyle habits of donors to help optimize valid stool donations. This research is conducted under a common protocol with regulatory approval to pool resources and standardize procedures. Healthy volunteers will be selected and included in the study to donate stool for preparing FMT as part of various research projects. Donors will be followed from selection through to six months after their last valid stool donation. The study aims to monitor donation frequency and validity over a 12-month period and beyond, with a focus on both temporary and permanent factors that might affect donor eligibility and stool quality. Participants will undergo screening and regular follow-up visits to assess health and stool donation validity. Researchers will collect data on clinical characteristics, lifestyle habits, reasons for non-eligibility or donation termination, and microbiota composition of valid donations. The primary outcome is the proportion of donors who make at least one valid stool donation within 12 months. The study will continue monitoring participants for up to five years to evaluate long-term participation and donation patterns.

Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials