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New treatment option for Bariatric Surgery
Official title Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery
ClinicalTrials.gov ID: NCT06192693
What this study is testing
What is Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution?
Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bariatric surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Obesity progresses worldwide with few effective treatments leading to a burst in Bariatric surgery (BS). France is the 3rd country in BS numbers yearly.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 65. Healthy volunteers may be eligible.
You may be able to join if
- patients :
- Adult patients from 18-65 years old
- T2D patients any severity of initial T2D disease before BS
- Who underwent Bariatric surgery (BS) 1 to 5 years before (Roux-en-Y gastric bypass or sleeve, patients with pre-BS BMI≥35kg/m²)
- Non-Diabetic remission (NDR) patients 1-year post-BS, defined as Hba1c\>6.5% and/or fasting glycaemia\>6.9mmol/l and/or receiving anti-diabetic drugs...
You likely can't join if
- patients :
- Type 1 diabetes
- Patients receiving antibiotics (ATB) at the selection time or within the 3 previous months (if agreeing to participate to the study, the patients...
- Immunosuppressive therapy
- Laxative treatments
- DR since BS (nor relapse patients detailed further in the protocol)
See the full eligibility criteria
- patients :
- Adult patients from 18-65 years old
- T2D patients any severity of initial T2D disease before BS
- Who underwent Bariatric surgery (BS) 1 to 5 years before (Roux-en-Y gastric bypass or sleeve, patients with pre-BS BMI≥35kg/m²)
- Non-Diabetic remission (NDR) patients 1-year post-BS, defined as Hba1c\>6.5% and/or fasting glycaemia\>6.9mmol/l and/or receiving anti-diabetic drugs for at least 2 months. We will rather select patients with...
- Patient compliant to 1rd year follow-up post-BS (who came to at least 2 among the three routine care follow-up visits during the first year (i.e. 3, 6 and 12M)
- Signature of the informed consent
- Affiliated to a social security regime (except AME)
- patients :
- Type 1 diabetes
- Patients receiving antibiotics (ATB) at the selection time or within the 3 previous months (if agreeing to participate to the study, the patients will be proposed randomization 3 months after stopping ATB)
- Immunosuppressive therapy
- Laxative treatments
- DR since BS (nor relapse patients detailed further in the protocol)
- Patients already recruited in another treatment studies study where a drug is being tested
- Pregnant or breastfeeding women
- Patient with contemporary disease such as intestine disease
- Patient under guardianship or curatorship
- Patient deprived of their liberty by a judicial or administrative decision Inclusion criteria donors:
- Age ≥ 18 years and \< 50 years
- Lean individuals (18\<BMI\<25kg/m²)
- Euglycemic: fasting glycemia \<6mmol/l; Hba1c \<5.9%
- Healthy: no current drug prescription (except contraception or pain killers other than AINS)
- Regular bowel movement in the morning defined as 1 stool/day at least
- Signature of the informed consent
- Subject with health insurance (except AME) Exclusion criteria donors:
- Familial history of obesity or diabetes and personal history of overweight/obesity
- Infectious risk
- Gastrointestinal disease
- Exclusion criteria according screening test to National Agency for the Safety of Medicines and Health Products (ANSM) recommendations
- Pregnancy or breastfeeding women
- Subject under guardianship or curatorship
- Subject deprived of their liberty by a judicial or administrative decision
The study team makes the final eligibility decision.
Where it's taking place
- 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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.