Using fecal microbiota transfer to improve diabetes control after bariatric surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of fecal microbiota transfer (FMT) on diabetes control in patients who have undergone bariatric surgery. The study aims to address the issue of deteriorating glycemic control in patients with Type 2 Diabetes (T2D) post-surgery by administering capsulized FMT or a placebo. Participants will be adults aged 18-65 with uncontrolled diabetes who had bariatric surgery 1 to 5 years prior. The trial will assess the impact of FMT on gut microbiota composition and its potential to improve diabetes management.

Why it matters

Who can join: the full rules

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

Where it's running

• Groupe hospitalier Pitié-Salpêtrière
  Paris, France Recruiting

Study contacts

• Study coordinator: Judith Aron-Wisnewsky, Pr
• Email: judith.aron-wisnewsky@aphp.fr
• Phone: +33 1 42 17 75 41

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.