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
303 weeks
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
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.
CONDITIONS
Official 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 kg/m² and 30 kg/m²
- Regular bowel movements with at least one stool every other day and a maximum of two stools per day
- Have health insurance (excluding AME)
- Provide informed written consent
You will not qualify if you...
- Known infections with HIV, HBV, HCV, or HTLV
- Lived more than 2 years in the intertropics zone 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
- 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
- History of gastrointestinal neoplasia or polyps
- Family history of gastrointestinal neoplasia 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
- Prone to hemorrhoids (at least one event in the last year)
- Active chronic illness except mild allergic diseases
- Serious allergy requiring hospitalization in the last 12 months
- Long-term curative treatment
- Allogeneic human or animal tissue or organ transplant
- Special diets affecting microbiota composition, except lactose-free, vegetarian, or vegan diets
- Pregnancy or breastfeeding
- Taking immunosuppressants or antineoplastic chemotherapy
- Under legal protection
- Participation in other interventional studies except stool donation
- Recent unprotected or multiple sexual partners within 4 months
- Sexual partner with multiple partners or sexually transmitted infections within 4 months
- Sex work or partner with HIV or hepatitis within 6 months
- Recent blood transfusion, piercing, tattoo, surgery, or hospitalization within 4 months
- Living with someone with an infectious disease within 4 months
- Recent dental care within 7 days
- Recent gastroenteritis within 3 months
- Recent infections or skin lesions within 15 days
- Recent COVID-19 infection or exposure within 28 days
- Recent monkeypox infection or exposure within 42 days
- Recent vaccination within 15 days
- Recent use of antibiotics, antifungals, NSAIDs, or corticosteroids within specified time frames
- Temporary or permanent criteria rechecked at each donation visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
LRIPH CRC-Est SAT
Paris, France, 75012
Actively Recruiting
Research Team
M
Mélissa Montil, Praticien attaché
CONTACT
H
Harry SOKOL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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