Fecal Microbiota Transplantation for Type 2 Diabetes Mellitus and Hashimoto's Thyroiditis | NCT07733232

NCT07733232

Overview

NCT ID: NCT07733232
Lead Sponsor: Shen XujunOTHER_GOV
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.
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Dec 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 38Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Xu Jun ShenContact
sxjsandy@126.com+8615906675015

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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