Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes

What Was Tested

The trial (not phased) is built around Semaglutide.

It had two arms (groups): Intervention group (experimental) and Control group (active comparator).

A comprehensive intervention combining fecal microbiota transplantation, calorie-restricted diet, and glucagon-like peptide-1 receptor agonist.

Conventional treatment with calorie-restricted diet and glucagon-like peptide-1 receptor agonist.

The registry classes the interventions as behavioral, biological and drug.

More on the Plan

This study is designed as a single-center, randomized, open-label, parallel-controlled trial.

The intervention period will be 24 weeks.

The primary endpoint is the percentage change in body weight from baseline to post-intervention.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-60 years;. Body mass index (BMI) ≥30 kg/m² and \<40 kg/m²;. Duration of type 2 diabetes mellitus \<1 year;. Non-smoker or smoking cessation \>3 months;. Voluntary signed informed consent with commitment to complete the entire study.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: inflammatory bowel disease (ibd), irritable bowel syndrome (ibs), or other organic intestinal diseases; autoimmune diseases, malignancies, or active infections;; others: pregnant or lactating women; currently participating in other clinical trials.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-04-30 with completion listed for 2027-01-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent change in body weight (time frame: From enrollment to the end of treatment at 24 weeks).

It also tracked 20 secondary outcomes, for example Change in glycated hemoglobin (HbA1c), Change in fasting insulin, Change in fasting plasma glucose, Change in total cholesterol, Change in low-density lipoprotein cholesterol and Change in high-density lipoprotein cholesterol.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.