Status:
RECRUITING
Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Bariatric Surgery
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 di...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06192693
Start Date
January 21 2024
End Date
February 1 2029
Last Update
February 17 2025
Active Locations (1)
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1
Groupe hospitalier Pitié-Salpêtrière
Paris, France, 75013