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

Efficacy of Fecal Microbiota Transplantation in Improving Metabolic Parameters and Immune Dysregulation in Patients With Concurrent Type 2 Diabetes Mellitus and Autoimmune Thyroid Disease.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM); FMT; Autoimmune Thyroid Disease
• Intervention / Treatment: Biological: Fecal microbiota transplantation oral capsules

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xu Jun Shen; Phone Number: +8615906675015; Email: sxjsandy@126.com
• Study Contact Backup: Name: Ling Ling Zhang; Phone Number: +8619706851581

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 and ≤ 65 years old.
2. Diagnosed with type 2 diabetes mellitus (T2DM).
3. Positive for thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb); thyroid ultrasonography indicates diffuse thyroid lesions.
4. 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.

Exclusion Criteria:

1. Subjects who have used antibiotics, probiotics or prebiotics within 4 weeks prior to screening.
2. Patients complicated with severe gastrointestinal diseases (e.g., inflammatory bowel disease, active gastrointestinal bleeding).
3. Patients receiving specialized treatment for hyperthyroidism (Graves' disease) or with a history of thyroid malignancy.
4. Patients with severe immunosuppression (neutrophil count < 1500/mm³, lymphocyte count < 500/mm³).
5. Patients with active severe gastrointestinal bleeding, intestinal perforation, or severe intestinal barrier/mucosal injury.
6. Patients with intestinal mucosal injury of unknown etiology.
7. Patients diagnosed with fulminant colitis or toxic megacolon.
8. Patients with active extraintestinal infection requiring treatment with broad-spectrum antibiotics.
9. Severe malnutrition (body mass index < 15 kg/m²) or severe hypoalbuminemia (serum albumin < 25 g/L).
10. Congenital or acquired immunodeficiency diseases.
11. 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).
12. Patients complicated with other autoimmune diseases.
13. Patients with severe hepatic or renal insufficiency.
14. Patients with malignant tumors.
15. Patients with known allergy to capsule ingredients.
16. Pregnant or lactating females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal microbiota transplantation group	Biological: Fecal microbiota transplantation oral capsules; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Body weight	baseline，week12，week24

Collaborators and Investigators

• Sponsor: Shen Xujun

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Therapeutics; Biological Therapy; Fecal Microbiota Transplantation
• Other Study ID Numbers: Zhelvyi Ethics【2026】No.12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The shared individual participant data include baseline demographic data, laboratory indicators, primary and secondary outcome measures collected at Week 12 and Week 24, adverse event records. Raw data will be de-identified to remove all personal identifiable information before sharing.
• IPD Sharing Time Frame: Start date: After study completion and publication (Week 24 follow-up finished and manuscript published) End date: 5 years after publication

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No