Poop power: what makes a perfect stool donor?
NCT ID NCT06478823
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial investigates healthy volunteers who donate stool for fecal microbiota transplantation (FMT), a procedure used to treat certain gut disorders. Researchers aim to identify factors that lead to valid donations, such as donor health and lifestyle, to streamline the donation process. Up to 400 healthy adults aged 18–50 will be followed for up to 12 months to see how many make at least one valid donation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stool donation
- What this could lead to
- If successful, this could make fecal microbiota transplantation more efficient and accessible for treating gut disorders.
- What could go wrong
- This is an observational study focused on donor characteristics, not a treatment trial. It may not directly improve patient outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 49 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years and \< 50 years * 17 kg/m² \< body mass index \< 30 kg/m² * Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day * Subject with health insurance (AME excepted) * Informed written consent Exclusion Criteria: Definitive non-inclusion criteria: 1. Infectious risk : \- Known HIV, HBV, HCV, HTLV infection * Residence of more than 2 years in the intertropics zone within the previous 5 years * Hospitalization abroad for more than 24 hours in the last 12 months (including a member of the healthy volunteers donor's entourage) * Risk factors for Creutzfeldt-Jakob disease (history: treatment with extractive growth hormone, a family case of transmissible spongiform subacute encephalopathy, surgery with opening of the dura or neurosurgery or invasive brain exploration before 1 January 1995, stay in United Kingdom for a duration greater than 1 year cumulatively between 1980 and 1996 or the presence of neurological or neuropsychiatric scalable recent clinical signs) * Previous history of typhoid fever, tuberculosis and malaria * Past or current injection drug user or regular use of other drug 2. Gastrointestinal disease: \- Personal or 1st degree family history of: inflammatory bowel disease or celiac disease * Personal history of irritable bowel syndrome * Previous history of gastrointestinal neoplasia or polyps * Family history of 1st degree gastrointestinal neoplasia or polyps before age 60 3. 1st degree family history of one of the following autoimmune or inflammatory disease : inflammatory arthritis, psoriasis, multiple sclerosis, type I diabetes, spondylitis, lupus and Basedow disease \- If family history unknown in the first degree, the donor is not eligible 4. Previous history of : * Subject prone to hemorrhoids (at least 1 event within the previous 1 year) * Subject with an active chronic illness (except active chronic mild allergic disease o (example: allergic rhinitis, chronic eczema…)) o Diagnosis of Gilbert's syndrome done by screening is not a chronic disease. The healthy volunteer donor will therefore remain eligible. * Serious allergy requiring hospitalization within the previous 12 months * Curative long-term treatment * Severe allergy requiring hospitalization in the last 12 months * Allogeneic human or animal tissue or organ transplant 5. Factors that may affect the composition of the intestinal microbiota: \- Special Diet (example: gluten-free...) * Lactose-free, vegetarian and vegan diets are permitted. * Pregnancy or breastfeeding * Taking immunosuppressants (eg calcineurin inhibitors, corticosteroids, biological agents, etc.) * Antineoplastic chemotherapy 6. Subject under legal protection 7. Participation in any other interventional study except studies for stool donation Temporary non-inclusion criteria 1. Infectious risk : \- Unprotected sexual intercourse with a new partner in the previous 4 months and/or sexual intercourse with several different persons within the previous 4 months \- sexual partner who has had more than 1 partner within the previous 4 months and/or \- sexual transmitted infection within the previous 4 months (healthy volunteer donor himself or sexual partner) \- Sexual relationship in exchange for money or drugs in the last 12 months. (healthy volunteer donor himself or sexual partner) \- Sexual relationship with a partner with positive serology for HIV, viral hepatitis B or C, in the last 6 months. \- Sexual relationship with a partner who has used intravenous drugs, doping substances \- Hospitalization abroad for more than 24 hours in the last 12 months (healthy volunteer or entourage) \- Travelling within the previous 6 months except : Germany, Austria, Belgium, Spain, Finland, Ireland, Italia, Luxembourg, Netherland, Portugal, Greece, Slovenia, Cyprus, Malta, Slovakia, Estonia , Bulgaria, Croatia , Hungary, Latvia , Lithuania, Poland , Romania, Czech Republic, the United Kingdom, Denmark, Norway, Sweden, Switzerland, USA, Iceland, Australia New Zealand, Japan, South Korea, Singapore, Israel or Canada. \- Blood transfusion, piercing (including earrings) or tattoo within the previous 4 months \- Surgery (all types) or hospitalization within the previous 4 months \- Person living under the same roof or sexual partner with an infectious or contagious disease (i.e who have been hospitalized) within the previous 4 months \- Blood exposure accident (for wound, pricking or projection ...) within the previous 4 months \- Dental care within the previous 7 days \- Gastroenteritis within the previous 3 months (defined by acute onset of diarrhea (\> 3 soft or liquid stools per day) and duration \< one week) \- Episode of infection or skin infection/lesion within the previous 15 days 2-Risk linked to Covid-19 \- Confirmed infection in the previous 28 days (after symptoms have ceased) * Clinical signs of suspected infection (chill, cough, fever, dyspnea, myalgia, asthenia, malaise, pharyngeal pain, anosmia , ageusia, rhinorrhea, chest pain, headache, diarrhea) in the previous 28 days (after the end of symptoms) * Having been in risky contact (according to the definition of Santé Publique France with a person whose infection is confirmed or suspected: "14 days after the last risky contact: if the recommended screening tests in the event of risky contact between D15-D28 are negative "In the 28 days preceding inclusion in the absence of a screening test. Healthcare professionals using recommended protective measures with COVID patients are not considered high-risk contacts 3- Monkeypox risk * Confirmed or suspected infection within the previous 42 days ( after beginning of symptoms) * Risky contact with a person with confirmed or suspected infection within the previous 21 days (from the date of last contact) 4- vaccination with a live attenuated vaccine during the last month 5- Chronic diarrhoea in the previous 3 months or chronic constipation (fewer than 3 bowel movements per week for more than 6 months) 6- Excessive alcohol consumption in the last 4 months. (French Public Health definition: 10 standard drinks per week and a maximum of 2 drinks per day) 7 - Factors that may affect the composition of the intestinal microbiota: * Taking antibiotic or antifungal (oral) in the previous 3 months before donation * Taking non-steroidal anti-inflammatory drugs (oral) in the previous month before donation * Taking corticosteroids (oral) in the previous 4 weeks before donation. Corticosteroids allowed if taken more than 4 weeks before donation. and not for an autoimmune or inflammatory disease. Temporary or permanent exclusion criteria: \- At each visit of the donation period, the temporary or definitive exclusion criteria (identical to the temporary or definitive non-inclusion criteria) will be rechecked
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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LRIPH CRC-Est SAT
RECRUITINGParis, Paris, 75012, France
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