Fecal Microbiota Transplantation for Type 2 Diabetes Mellitus and Hashimoto's Thyroiditis

NCT07733232 | Not Yet Recruiting Phase 4

• 1 other identifier: Zhelvyi Ethics【2026】No.12
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) can improve metabolic control and immune function in adults with both type 2 diabetes and Hashimoto's thyroiditis (an autoimmune thyroid disease). It will also learn about the safety of FMT in these patients. The main questions it aims to answer are: Can FMT lower blood sugar levels (HbA1c, fasting blood glucose, and 2-hour post-meal blood glucose) in participants with type 2 diabetes? Can FMT reduce thyroid autoantibody levels (TPOAb and TgAb) in participants with Hashimoto's thyroiditis? This is a single-arm study, meaning all participants will receive the same FMT treatment. Researchers will compare each participant's results before and after the intervention to see if FMT has an effect. Participants will: Complete baseline tests including blood work and stool sample collection during the 2-week screening period Take 40 oral FMT capsules by mouth over about 1.5 hours under medical supervision at the start of the study Keep taking their usual diabetes and thyroid medications at the same dose throughout the study, unless their doctor says otherwise Return for follow-up visits and tests at 12 weeks and 24 weeks after the FMT treatment

Conditions

Autoimmune Thyroid Disease; Type 2 Diabetes Mellitus (T2DM); FMT

Outcome Measures

Primary Outcomes (5)

• Glycated Hemoglobin(HbA1c)

  baseline，week 12，week 24

• Fasting blood glucose

  baseline，week12，week24

• 2-hour postprandial blood glucose

  baseline，week12，week24

• Thyroid Peroxidase Antibody(TPOAb)

  baseline，week12，week24

• Thyroglobulin Antibody(TgAb)

  baseline，week12，week24

Secondary Outcomes (6)

• Recovery of characteristic gut microbiota

  baseline，week 12，week 24

• Triglycerides

  baseline，week12，week24

• Total cholesterol

  baseline，week12，week24

• Uric acid

  baseline，week12，week24

• Fasting Insulin

  baseline，week12，week24

Study Arms (1)

Fecal microbiota transplantation group

EXPERIMENTAL

Biological: Fecal microbiota transplantation oral capsules

Interventions

Fecal microbiota transplantation oral capsules BIOLOGICAL

All subjects received a single standardized fecal microbiota transplantation (FMT) intervention at Week 0 under unified protocols. After fasting, each subject took 40 standardized fecal microbiota suspension capsules in divided doses within 1.5 hours (2-3 capsules each time, swallowed with warm water).

Fecal microbiota transplantation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 65 years old.
• Diagnosed with type 2 diabetes mellitus (T2DM).
• Positive for thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb); thyroid ultrasonography indicates diffuse thyroid lesions.
• The regimens of hypoglycemic drugs and thyroid-related basic treatments (including drug types and dosages) have remained stable for at least 3 months before enrollment.

You may not qualify if:

• Subjects who have used antibiotics, probiotics or prebiotics within 4 weeks prior to screening.
• Patients complicated with severe gastrointestinal diseases (e.g., inflammatory bowel disease, active gastrointestinal bleeding).
• Patients receiving specialized treatment for hyperthyroidism (Graves' disease) or with a history of thyroid malignancy.
• Patients with severe immunosuppression (neutrophil count \< 1500/mm³, lymphocyte count \< 500/mm³).
• Patients with active severe gastrointestinal bleeding, intestinal perforation, or severe intestinal barrier/mucosal injury.
• Patients with intestinal mucosal injury of unknown etiology.
• Patients diagnosed with fulminant colitis or toxic megacolon.
• Patients with active extraintestinal infection requiring treatment with broad-spectrum antibiotics.
• Severe malnutrition (body mass index \< 15 kg/m²) or severe hypoalbuminemia (serum albumin \< 25 g/L).
• Congenital or acquired immunodeficiency diseases.
• Patients who have recently received high-risk immunosuppressants or cytotoxic drugs (e.g., rituximab, doxorubicin), or medium-to-high dose glucocorticoids (e.g., prednisone \>= 20 mg per day for more than 4 consecutive weeks).
• Patients complicated with other autoimmune diseases.
• Patients with severe hepatic or renal insufficiency.
• Patients with malignant tumors.
• Patients with known allergy to capsule ingredients.

Sponsors & Collaborators

• Shen Xujun: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Xu Jun Shen

CONTACT

+8615906675015; sxjsandy@126.com

Ling Ling Zhang

CONTACT

+8619706851581

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start date: After study completion and publication (Week 24 follow-up finished and manuscript published) End date: 5 years after publication
• Access Criteria: Only qualified clinical research investigators may submit formal written data access applications to the principal investigator. Approved applicants can obtain de-identified individual participant data, study protocol, statistical analysis plan and informed consent form. Data will be delivered via encrypted electronic files after signing a data use agreement. Data application requests shall be submitted by email to the principal investigator; there is no dedicated public web portal for online application. All data access inquiries and completed application documents should be sent to the principal investigator via official email.