RecruitingPhase 2NCT05253768

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

Safety and Efficacy of Human Microbiota Transplantation for Overweight and Obese Type 2 Diabetes Mellitus ( SETOM ): A Randomized, Double-blind, Placebo-controlled Clinical Study


Sponsor

Zhujiang Hospital

Enrollment

39 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a fecal microbiota transplant (FMT) — transferring gut bacteria from a healthy donor — can help improve blood sugar control in people who are overweight or obese and have type 2 diabetes. Researchers believe that changing the balance of gut bacteria may improve how the body responds to insulin. **You may be eligible if...** - You have been diagnosed with type 2 diabetes for at least 2 months - You are currently managing your blood sugar only through diet and exercise, without medication for the last 8 weeks - Your HbA1c (a 3-month blood sugar average) is between 7.0% and 10.0% - Your BMI is between 24 and 35 (overweight to obese range) - You are willing to maintain your usual diet and exercise habits throughout the study **You may NOT be eligible if...** - You have type 1 diabetes, gestational diabetes, or another special type of diabetes - You have gastrointestinal conditions such as IBS or inflammatory bowel disease - You are pregnant - You have serious uncontrolled health conditions - You have recently taken antibiotics or medications that affect the gut Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFecal 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.

OTHERnormal 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.


Locations(1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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NCT05253768


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