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Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery

RecruitingPhase 3Ages 18 Years - 65 YearsAllAssistance Publique - Hôpitaux de Paris
NCT06192693 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Obesity progresses worldwide with few effective treatments leading to a burst in Bariatric surgery (BS). France is the 3rd country in BS numbers yearly. BS improves diabetes (T2D) and even induces diabetes remission (DR) in 60% of patients. Thus, an expert consensus recommended extending BS to T2D with BMI≥30kg/m² with uncontrolled glycaemia, anticipating even more BS. Glycaemic control further deteriorates in the longer term in non DR (NDR) patients and relapse occurs in some DR patients, urging the need to add new therapy to control glycaemia and provide new recommendations in the future. Obesity and T2D are characterized by gut microbiota dysbiosis with low to very low microbial gene richness (MGR). About 75% of patients' candidates for BS are in the low MGR category. Whereas BS modifies microbiota composition and increases MGR 1-year post-BS, we demonstrated that only a few patient

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📋 Eligibility rules (as published)
Inclusion 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 uncontrolled diabetes with Hba1c\>7% and willing to receive proton pump inhibitor (PPI) * 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) Exclusion Criteria 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 interventional 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
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What it tests

  • Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution
  • Capsulized placebo transfer containing dilution solution
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Where

1 site
Groupe hospitalier Pitié-Salpêtrière
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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