Safety and Efficacy of Human Microbiota Transplantation for Overweight and Obese Type 2 Diabetes Mellitus

PHASE2RecruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

March 31, 2024

Primary Completion Date

March 31, 2025

Study Completion Date

December 31, 2025

Conditions
Type 2 Diabetes MellitusOverweight and Obesity
Interventions
BIOLOGICAL

Fecal microbiota transplant (FMT)

"Patients will randomized to a fecal microbiota transplantation by using a nasointestinal tube for 3 times in 4 weeks(0,2,4) without undergoing an enema before the treatment.~The amount of FMT is 200ml at one time. Patients are given the same lifestyle guidance and nutritional advice."

OTHER

normal saline and glycerin/food coloring

"Patients will receive an equivalent volume of normal saline and glycerin/food coloring via a nasointestinal tube (sham transplantation) for 3 times in 4 weeks(0,2,4) without undergoing an enema before the treatment.~The amount of placebo FMT is 200ml at one time. Patients are given the same lifestyle guidance and nutritional advice."

Trial Locations (1)

510000

RECRUITING

Zhujiang Hospital of Southern Medical University, Guangzhou

All Listed Sponsors
lead

Zhujiang Hospital

OTHER

collaborator

Dongguan People's Hospital

OTHER_GOV

collaborator

Shenzhen Hengsheng Hospital

UNKNOWN

collaborator

Shaoguan Qide Hospital

UNKNOWN

collaborator

Shaoguan First People's Hospital

UNKNOWN

collaborator

Zhaoqing First People's Hospital

UNKNOWN

collaborator

Suixi Hospital of Guangdong Medical University

UNKNOWN

collaborator

Shantou Central Hospital

OTHER

collaborator

People's Hospital of Xinxing County

UNKNOWN

collaborator

Shantou Longhu People's Hospital

UNKNOWN