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

NCT07599046 | Not Yet Recruiting DMC

• 1 other identifier: 2025-183-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of the efficacy of fecal microbiota transplantation added to calorie-restricted diet and semaglutide versus calorie-restricted diet and semaglutide alone for weight loss and metabolic improvement in patients with moderate to severe obesity and type 2 diabetes mellitus.

Conditions

Obesity Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; Obesity; Fecal microbiota transplantation; Calorie-restricted diet; Semaglutide

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight

  The percentage change in body weight from baseline to follow-up visit (week 24) is presented. Body weight (kg) will be measured using a calibrated electronic scale operated by research personnel who have undergone standardized training.

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (20)

• The proportion of participants achieving ≥5% body weight reduction

  From enrollment to the end of treatment at 24 weeks

• Change in glycated hemoglobin (HbA1c)

  Baseline, Week 12, and Week 24

• Change in fasting insulin

  Baseline, Week 12, and Week 24

• Change in fasting plasma glucose

  Baseline, Week 12, and Week 24

• Change in total cholesterol

  Baseline, Week 12, and Week 24

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Biological: Fecal microbiota transplantation (FMT); Drug: Semaglutide (1 Mg Dose); Behavioral: Calorie-restricted diet

Control group

ACTIVE COMPARATOR

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

Drug: Semaglutide (1 Mg Dose); Behavioral: Calorie-restricted diet

Interventions

Fecal microbiota transplantation (FMT) BIOLOGICAL

Donor Selection: Healthy lean donors with BMI \<23 kg/m² will be selected following rigorous health screening. Capsule Preparation: Donor fecal samples will be homogenized, filtered to remove debris, lyophilized, and encapsulated in enteric-coated capsules. Oral FMT capsule dosage: 10 capsules per dose, once daily, for 6 consecutive days each month.

Also known as: FMT

Intervention group

Semaglutide (1 Mg Dose) DRUG

Semaglutide 1.0 mg subcutaneous injection once weekly

Also known as: glucagon-like peptide-1 receptor agonist, GLP-1 receptor agonist

Control group; Intervention group

Calorie-restricted diet BEHAVIORAL

Daily caloric intake will be individualized based on physical activity level: 25 kcal/kg/day for individuals with light-to-moderate physical activity and 30 kcal/kg/day for those with heavy physical activity.

Also known as: CRD

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Complicated with severe hepatic or renal insufficiency (alanine aminotransferase/aspartate aminotransferase \[ALT/AST\] \>3 times the upper limit of normal, or estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73 m²);
• 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.

Sponsors & Collaborators

• Eighth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Eighth Affiliated Hospital, Sun Yat-sen University

Shenzhen, Guangdong, 518033, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Fecal Microbiota Transplantation; semaglutide; Caloric Restriction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Diet Therapy; Nutrition Therapy; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Yunfeng Shen, Ph.D

CONTACT

0755-83982222; shenyf26@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: May 20, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)