Gastro-Intestinal DisorderVIOLONSELNCT06478823
Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials
A study testing Stools donation in people with Gastro-Intestinal Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastro-Intestinal Disorder
- What is being tested?
- Stools donation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2024to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Definitive non-inclusion criteria:
- 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)
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- Previous history of typhoid fever, tuberculosis and malaria
- Past or current injection drug user or regular use of other drug
- 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
- 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
- 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
- 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
- Subject under legal protection
- Participation in any other interventional study except studies for stool donation
- Temporary non-inclusion criteria
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
LRIPH CRC-Est SAT
Paris, Paris, 75012
Melissa MONTIL
Harry SOKOL, 00 33 1 49 28 31 62, harry.sokol@aphp.fr
About this study
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.
Read the detailed description
If the ANSM recommendations govern FMT (Fecal Microbiota Transplantation) in clinical trials, the selection, inclusion of Healthy Volunteer Donors (HVD), then the collection and validation of these stool donations is complex and not very effective. It therefore seems essential to identify the limiting factors and the characteristics of HVD to optimize the number of valid stool donations.
Healthy voluntary donors of stools for the preparation of TMF (Healthy Volunteer Donors, -TMF) for trials to evaluate its effectiveness in various pathologies will be selected, included and followed in a common protocol (ANSM agreement obtained) in order to facilitate this entire process and pool resources. This will allow us to describe the clinical characteristics and lifestyle habits of Healthy Volunteer Donors associated with the validity of stool donations.
- Conditions
- Gastro-Intestinal Disorder
- Being tested
- Stools donation
- Keywords
- Healthy Volunteer stool Donors, Stools donations, Fecal microbiota transplantation
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stools donationOther
Healthy volunteer donors included in the selection process to donate stool for the preparation of a TMF as part of research projects.
Donors will be followed from their selection until 6 months after their last valid stool donation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers for stool donation | Experimental | Not described Receives: Other: Stools donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of HVD included who made at least 1 valid stool donation in the 12 months following their inclusion
A valid stool donation is a donation that complies with all the clinical and biological recommendations of the ANSM (Defining the rules of good practice relating to the collection, control, storage, traceability and transport of human stool samples as provided for in Article L. 513-11-2 of the Public Health Code. Decision of 7 April 2025.")
Define among the Healthy Volunteer Donors-TMFs (HVD ) included, the number of (HVD ) having made at least 1 valid stool donation.
Measured: 12 months
Secondary outcomes (9)
Proportion of "good donors": included donors having made at least 5 valid stool donations in the 12 months following their inclusion.
A valid stool donation is a donation that complies with all the clinical and biological recommendations of the ANSM
Define among HVD included, "good donors" having made at least 5 valid stool donations
Measured: 12 months
Description of the clinical characteristics of HVD performing stool donation
Description of clinical characteristics (average age, average BMI) of donors who made at least 1 valid stool donation within 12 months following their inclusion and comparison with those of donors who did not not having made valid donations.
Measured: 12 months
Description of the lifestyle habits of HVD performing stool donation
Description of the lifestyle habits (lifestyle : profession, eating habits) of donors who made at least 1 valid stool donation within 12 months following their inclusion and comparison with those of donors who did not not having made valid donations.
Measured: 12 months
Reasons for non-eligibility during the inclusion visit or during the phone screening
Description of the reasons for non-eligibility during the inclusion visit or during the phone screening (non-inclusion criteria, availability, tolerance/acceptance of blood and nasopharyngeal samples, geographical distance, compensation amount, etc.) in order to evaluate the factors limiting the eligibility of HVD
Measured: 5 years
Factors limiting the number of donations made by HVD per donation period of 28 days maximum
Reasons for not carrying out or no preparation stool donation: availability HVD , ability to make a donation in hospital, tolerance/acceptance of blood and nasopharyngeal samples, possibility of stool preparation at the pharmacy, biological abnormalities, criteria for transitional or permanent exclusions
Measured: 12 months
Evaluate the membership of participation of HVD
Number of periods of donations made, regularity of donations, motivation for participation in the study collected by the investigator
Measured: 5 years
Evaluate the duration of participation of HVD
Duration of participation in the study collected by the investigator
Measured: 5 years
Reasons for premature termination or non-validation of stools
Reasons for premature termination or non-validation of stools: biological, viral, bacteriological, hematological abnormalities, HVD clinical anomaly, investigator decision HVD decision in order to assess the causes of premature termination of HVD and non-validation of stool donations
Measured: 5 years
Assess the characteristics of the microbiota of valid donations
Composition of the microbiota of HVD
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start8 Jul 2024
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- CRB-SAT BARM APHP.SU, CRSA UMRS 938
- Responsible party
- Sponsor
- Investigators
- Mélissa Montil, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478823
- Sponsor's protocol ID
- APHP220606
- Other IDs
- 2022-A01401-42
- Acronym
- VIOLONSEL
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials
- ClinicalTrials.gov ID
- NCT06478823
- Acronym / sponsor ID
- VIOLONSEL / APHP220606
- Conditions
- Gastro-Intestinal Disorder
- Keywords
- Healthy Volunteer stool Donors, Stools donations, Fecal microbiota transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- CRB-SAT BARM APHP.SU, CRSA UMRS 938
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If the ANSM recommendations govern FMT (Fecal Microbiota Transplantation) in clinical trials, the selection, inclusion of Healthy Volunteer Donors (HVD), then the collection and validation of these stool donations is complex and not very effective. It therefore seems essential to identify the limiting factors and the characteristics of HVD to optimize the number of valid stool donations.
Healthy voluntary donors of stools for the preparation of TMF (Healthy Volunteer Donors, -TMF) for trials to evaluate its effectiveness in various pathologies will be selected, included and followed in a common protocol (ANSM agreement obtained) in order to facilitate this entire process and pool resources. This will allow us to describe the clinical characteristics and lifestyle habits of Healthy Volunteer Donors associated with the validity of stool donations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers for stool donation | Experimental | Other: Stools donation |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (59 listed)
- Infectious risk :
- Gastrointestinal disease:
- 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
- Previous history of :
- Factors that may affect the composition of the intestinal microbiota:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stools donationHealthy volunteer donors included in the selection process to donate stool for the preparation of a TMF as part of research projects. Donors will be followed from their selection until 6 months after their last valid stool donation. | Other | Healthy volunteers for stool donation |
Primary outcome
Proportion of HVD included who made at least 1 valid stool donation in the 12 months following their inclusion
Time frame: 12 months
A valid stool donation is a donation that complies with all the clinical and biological recommendations of the ANSM (Defining the rules of good practice relating to the collection, control, storage, traceability and transport of human stool samples as provided for in Article L. 513-11-2 of the Public Health Code. Decision of 7 April 2025.") Define among the Healthy Volunteer Donors-TMFs (HVD ) included, the number of (HVD ) having made at least 1 valid stool donation.
9 secondary outcomes
Proportion of "good donors": included donors having made at least 5 valid stool donations in the 12 months following their inclusion.
Time frame: 12 months
Description of the clinical characteristics of HVD performing stool donation
Time frame: 12 months
Description of the lifestyle habits of HVD performing stool donation
Time frame: 12 months
Reasons for non-eligibility during the inclusion visit or during the phone screening
Time frame: 5 years
Factors limiting the number of donations made by HVD per donation period of 28 days maximum
Time frame: 12 months
Evaluate the membership of participation of HVD
Time frame: 5 years
Evaluate the duration of participation of HVD
Time frame: 5 years
Reasons for premature termination or non-validation of stools
Time frame: 5 years
Assess the characteristics of the microbiota of valid donations
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mélissa Montil principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stools donation in people with Gastro-Intestinal Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 59 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélissa Montil, Praticien attaché (00 33 1 71 97 08 10, melissa.montil@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of HVD included who made at least 1 valid stool donation in the 12 months following their inclusion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.