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

Official title

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

Overview

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

Interventions

• 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).

Primary outcome measures

• Glycated Hemoglobin(HbA1c) [Time frame: baseline，week 12，week 24]
• Fasting blood glucose [Time frame: baseline，week12，week24]
• 2-hour postprandial blood glucose [Time frame: baseline，week12，week24]
• Thyroid Peroxidase Antibody(TPOAb) [Time frame: baseline，week12，week24]
• Thyroglobulin Antibody(TgAb) [Time frame: baseline，week12，week24]

Secondary outcome measures (6)

• Recovery of characteristic gut microbiota [Time frame: baseline，week 12，week 24]
• Triglycerides [Time frame: baseline，week12，week24]
• Total cholesterol [Time frame: baseline，week12，week24]
• Uric acid [Time frame: baseline，week12，week24]
• Fasting Insulin [Time frame: baseline，week12，week24]
• Body weight [Time frame: baseline，week12，week24]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Pregnant or lactating females.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07733232 · Zhelvyi Ethics【2026】No.12

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗