Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery

PHASE3RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

January 21, 2024

Primary Completion Date

February 28, 2029

Study Completion Date

February 28, 2029

Conditions
Bariatric SurgeryType 2 Diabetes
Interventions
DRUG

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

"1 FMT=30 capsulized FMT given during 2 days in several intakes per day (3 intakes per day).~FMT will be performed at baseline after randomization. Further treatment(s) will be given again at 6 and 12 weeks if we do not observe a change of Hba1c of at least -0.15% in patients who have Hba1c at inclusion \<7%; of at least -0.4% in patients who have Hba1c at inclusion ≤8% and of at least -0.7% in patients who have Hba1c at inclusion \>8%."

DRUG

Capsulized placebo transfer containing dilution solution

"1 Placebo of FMT=30 capsulized given during 2 days in several intakes per day (3 intakes per day).~Placebo of FMT will be performed at baseline after randomization. Further treatment(s) will be given again at 6 and 12 weeks if we do not observe a change of Hba1c of at least -0.15% in patients who have Hba1c at inclusion \<7%; of at least -0.4% in patients who have Hba1c at inclusion ≤8% and of at least -0.7% in patients who have Hba1c at inclusion \>8%."

Trial Locations (1)

75013

RECRUITING

Groupe hospitalier Pitié-Salpêtrière, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER