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Clinical Trial Details

Trial ID: L6970
Source ID: NCT06192693
Associated Drug: Capsulized Fecal Microbiota Transfer Containing The Healthy Feces + Stool Dilution Solution
Title: Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery
Acronym: DRIFTER
Status: RECRUITING
Study Results: NO
Results:
Conditions: Bariatric Surgery|Type 2 Diabetes
Interventions: DRUG: Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution|DRUG: Capsulized placebo transfer containing dilution solution
Outcome Measures: Primary: Hba1c change from baseline to 6 months post randomization, At baseline and at 6 months after randomization | Secondary: Evolution of Hba1c from baseline to 2 years post-randomization, At baseline and at 6 weeks, 12 weeks, 18 weeks, 24 weeks, 1 year and 2 years post randomization|Evolution of C-peptide from baseline to 2 years post-randomization, At baseline and at 6 weeks, 12 weeks, 18 weeks, 24 weeks, 1 year and 2 years post randomization|Evolution of insulin secretion from baseline to 24 weeks using the HOMA-B calculator, Equal to 20 x fasting insulin (μIU/ml)/ fasting glucose (mmol/ml) - 3.5, At baseline and at 24 weeks post-randomization|Evolution of insulin resistance from baseline to 24 weeks, we will use the HOMA-IR (= fasting insulin (μIU/ml) × fasting glucose (mmol/ml)/ 22.5) and Disse index (=Disse 12\*((2.5\*(HDL-total cholesterol)-NEFA)-insulin)) which are two complementary markers to evaluate insulin resistance using different parameters, At baseline and at 24 weeks post-randomization|Glycaemia profile (using glycemic holter) changes from baseline to 6 weeks and 24 weeks, Glycemic holter will be placed on the patient for 3 days at baseline, 6 weeks and 6 months and will collect glycemic curve excursions that will further be compared at the different visits (baseline, 6 and 24 weeks). We will analyse the % and duration of hyperglycemia and hypoglycaemia and the % of time and duration at glycemic target at the different visits (baseline, 6 and 24 weeks), At baseline and at 6 weeks and 24 weeks post-randomization|Number of anti-diabetic (antiT2D) drugs, The number of concomitant anti-diabetic drugs will be analysed, At baseline and at 1 and 2 years post-randomization|Type of antiT2D drugs, The type of anti-diabetic drugs will be analysed, At baseline and at 1 and 2 years post-randomization|Number of patients reaching Diabetic Remission (DR), At baseline and at 24 weeks, 1 and 2 years post-randomization|Proportion of patient needing a "safety" glucose lowering treatment to control Hba1c despite FMTs (or placebo), From baseline to 2 years post-randomization|Evaluate FMT safety, Evaluate safety and AE by a systematic screening regarding fever, bloating, diarrhoea, regurgitation at each visit, From baseline to 2 years post-randomization|Evaluate quality of life, Evaluate changes in quality of life after capsulized FMT (baseline vs. after FMT and between treatment groups using SF36 questionnaire), At baseline and at 6 weeks, 12 weeks, 18 weeks, 24 weeks, 1 year and 2 years post randomization
Sponsor/Collaborators: Sponsor: Assistance Publique - Hôpitaux de Paris
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 54
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-21
Completion Date: 2029-02
Results First Posted:
Last Update Posted: 2025-02-17
Locations: Groupe hospitalier Pitié-Salpêtrière, Paris, 75013, France
URL: https://clinicaltrials.gov/show/NCT06192693