drugset / Trial / NCT05253768
Safety and Efficacy of Human Microbiota Transplantation for Overweight and Obese Type 2 Diabetes Mellitus
Phase 2
Unknown
39 enrolled
Zhujiang Hospital
Dongguan People's Hospital · collabFirst People's Hospital of Zhaoqing · collabPeople's Hospital of Xinxing County · collabShantou Central Hospital · collabShantou Longhu People's Hospital · collabShaoguan First People's Hospital · collabShaoguan Qide Hospital · collabShenzhen Hengsheng Hospital · collabSuixi Hospital of Guangdong Medical University · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose is to evaluate whether the percentage of body weight change from baseline to week 12 is higher than that in the placebo group. In this randomized, double-blind, placebo-controlled study, 39 patients fulfilling the study criteria will be enrolled in the study. Patients will be randomized(2:1) to either FMT or placebo.
Timeline
- Start
- 2024-03
- Primary completion
- 2025-03
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fecal Microbiota Transplant (FMT) | Unknown | 200 ml | Other |