BridgeMD
New treatment option for Gastro-Intestinal Disorder
Official title Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials
ClinicalTrials.gov ID: NCT06478823
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- Previous history of typhoid fever, tuberculosis and malaria
See the full eligibility 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
- 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...
- 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...
- 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...
- 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 treatment 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.