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Fecal microbiota transfer to improve diabetes control post-bariatric surgery
EU CTIS ID: 2024-511870-65-00
What this study is testing
To assess Fecal microbiota transfer (FMT) efficacy on Hba1c change from baseline to 6 months (6M=24W) follow-up, in non-diabetic Remission (NDR) patients who underwent Bariatric surgery (BS) 1 to 5 years ago.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For patients : Adult patients from 18-65 years old
- For donors : Euglycemic: fasting glycemia <6mmol/l; Hba1c <5.9%
- For donors : Healthy no current drug prescription (except contraception or pain killers other than AINS)
- For donors : Regular bowel movement in the morning defined as 1 stool/day at least
- For donors : Signature of the informed consent
- For donors : Subject with health insurance (except AME)
You likely can't join if
- For patients : Type 1 diabetes
- For patients : Patient under guardianship or curatorship
- For donors : Familial history of obesity or diabetes and personal history of overweight/obesity
- For donors : Infectious risk (for more information see the protocol)
- For donors : Gastrointestinal disease (for more information see the protocol)
- For donors : Personal or 1st degree family history of autoimmune or inflammatory disease (inflammatory arthritis, psoriasis, multiple sclerosis, type I diabetes, Hashimoto…)
See the full eligibility criteria
Who can join
- For patients : Adult patients from 18-65 years old
- For donors : Euglycemic: fasting glycemia <6mmol/l; Hba1c <5.9%
- For donors : Healthy no current drug prescription (except contraception or pain killers other than AINS)
- For donors : Regular bowel movement in the morning defined as 1 stool/day at least
- For donors : Signature of the informed consent
- For donors : Subject with health insurance (except AME)
- For patients : T2D patients any severity of initial T2D disease before BS
- For patients : Who underwent Bariatric surgery (BS) 1 to 5 years before (Roux-en-Y gastric bypass or sleeve, patients with pre-BS BMI≥35kg/m²)
- For patients : 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 uncontrolled diabetes with Hba1c>7% and willing to receive proton pump inhibitor (PPI)
- For patients : 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)
- For patients : Signature of the informed consent
- For patients : Affiliated to a social security regime (except AME)
- For donors : Age ≥ 18 years and < 50 years
- For donors : Lean individuals (18
What rules you out
- For patients : Type 1 diabetes
- For patients : Patient under guardianship or curatorship
- For donors : Familial history of obesity or diabetes and personal history of overweight/obesity
- For donors : Infectious risk (for more information see the protocol)
- For donors : Gastrointestinal disease (for more information see the protocol)
- For donors : Personal or 1st degree family history of autoimmune or inflammatory disease (inflammatory arthritis, psoriasis, multiple sclerosis, type I diabetes, Hashimoto…)
- For donors : Factors that may affect the composition of the intestinal microbiota (Special Diet - exclusion diet, vegetarian diet) /Taking immunosuppressants - eg calcineurin inhibitors, corticosteroids, biological agents, etc. / Chemotherapy / Subject with a chronic illness / Curative long-term treatment
- For donors : Exclusion criteria according screening test : 1/Positive result for one of the contagious diseases testing blood and stool, excepting for IGG positive EBV, CMV and toxoplasma serology according to ANSM recommendations and only positive Ac HBS HBV witness of post-vaccination immunity and HAV Healed / 2 - Carrier of multiresistant bacteria / 3- - Abnormal biological test at inclusion suggesting a pathology: fasting blood glucose, Hba1c, blood count, chemistry panel with determination of urea and creatinine, liver function tests (AST, ALT, GGT, PAL, bilirubin), CRP, hemostasis
- For donors : Pregnancy or breastfeeding women
- For donors : Subject under guardianship or curatorship
- For donors : Subject deprived of their liberty by a judicial or administrative decision
- For patients : Patient deprived of their liberty by a judicial or administrative decision
- For donors : Temporary donor’s exclusion criteria - Infectious risk (for mors information see protocol)
- For patients : 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)
- For patients : Immunosuppressive therapy
- For patients : Laxative treatments
- For patients : DR since BS (nor relapse patients detailed further in the protocol)
- For patients : Patients already recruited in another interventional studies study where a drug is being tested
- For patients : Pregnant or breastfeeding women
- For patients : Patient with contemporary disease such as intestine disease
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.