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

NCT05253768 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Shenzhen Hengsheng Hospital

    collaborator UNKNOWN

  • Shaoguan Qide Hospital

    collaborator UNKNOWN

  • Shaoguan First People's Hospital

    collaborator UNKNOWN

  • Zhaoqing First People's Hospital

    collaborator UNKNOWN

  • Suixi Hospital of Guangdong Medical University

    collaborator UNKNOWN

  • Shantou Central Hospital

    collaborator OTHER

  • People's Hospital of Xinxing County

    collaborator UNKNOWN

  • Shantou Longhu People's Hospital

    collaborator UNKNOWN

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Hong Chen, MD · Zhujiang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-03-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05253768 on ClinicalTrials.gov