Actively Recruiting
Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-07-23
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
C
CRB-SAT BARM APHP.SU
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Healthy Volunteer Donors (HVD) who provide stool samples for Fecal Microbiota Transplantation (FMT) trials. The goal is to understand the factors that limit the collection and validation of stool donations and identify the characteristics of donors to improve the effectiveness of stool donation processes. This study addresses challenges made more complex by new COVID-19 recommendations and aims to optimize the availability of valid stool donations. Healthy volunteers will be selected and included to donate stool for research projects evaluating FMT in various diseases. Donors will be monitored from selection until six months after their last valid stool donation under a common protocol that pools resources. The study follows ANSM recommendations and collects clinical and lifestyle information to relate donor characteristics to stool donation success. Participants will be followed for up to 12 months to measure the proportion who make at least one valid stool donation, with additional evaluations of clinical and lifestyle factors, reasons for non-eligibility or donation failure, and microbiota characteristics of valid donations. Some outcomes are monitored up to five years, including participation duration and reasons for ending donations. Donors will have regular assessments to support stool donation and data collection throughout the study.
CONDITIONS
Brief Title
Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and less than 50 years
- Body mass index between 17 and 30 kg/m²
- Regular bowel movements, at least one stool every other day and no more than two stools per day
- Subject has health insurance (AME excluded)
- Provided informed written consent
You will not qualify if you...
- Known infections with HIV, HBV, HCV, or HTLV
- Residence more than 2 years in intertropical zones within the last 5 years
- Hospitalization abroad for more than 24 hours in the last 12 months (including close contacts)
- Risk factors for Creutzfeldt-Jakob disease (including certain medical history and stays in the UK between 1980 and 1996)
- Previous history of typhoid fever, tuberculosis, or malaria
- Past or current injection drug use or regular drug use
- Personal or first-degree family history of inflammatory bowel disease or celiac disease
- Personal history of irritable bowel syndrome, chronic constipation, or chronic diarrhea
- Previous gastrointestinal cancer or polyps
- Family history of gastrointestinal cancer or polyps before age 60
- First-degree family history of autoimmune or inflammatory diseases such as arthritis, psoriasis, multiple sclerosis, type I diabetes, spondylitis, lupus, or Basedow disease
- History of hemorrhoids within the past year
- Active chronic illness except mild allergic diseases
- Serious allergy requiring hospitalization within the past 12 months
- Long-term curative treatment
- Organ or tissue transplant
- Special diets affecting microbiota composition (gluten-free excluded; lactose-free, vegetarian, vegan allowed)
- Pregnancy or breastfeeding
- Use of immunosuppressants or chemotherapy
- Subject under legal protection
- Participation in other interventional studies except stool donation studies
- Temporary exclusions include recent risky sexual behavior, recent hospitalizations or surgeries, recent infections, recent vaccinations, recent antibiotic or anti-inflammatory drug use, and others as detailed in criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 12 months or until 6 months after last valid stool donation
Participants donate stool samples for the preparation of fecal microbiota transplantation and are followed from their selection until 6 months after their last valid stool donation.
Regular stool donation visits over the donation period
Trial Site Locations
Total: 1 location
1
LRIPH CRC-Est SAT
Paris, France, 75012
Actively Recruiting
Research Team
M
Mélissa Montil, Praticien attaché
H
Harry SOKOL
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here