54
Participants
Start Date
January 21, 2024
Primary Completion Date
February 28, 2029
Study Completion Date
February 28, 2029
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%."
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%."
RECRUITING
Groupe hospitalier Pitié-Salpêtrière, Paris
Assistance Publique - Hôpitaux de Paris
OTHER