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NCT07733232Not yet recruitingPhase 4

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.

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

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 (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
38 (estimated)
First submitted
18 Jul 2026
Start date
1 Aug 2026
Primary completion date
31 Dec 2027
Lead sponsor
Shen Xujun
NCT number
NCT07733232

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 38
  • From 1 Aug 2026 to the primary completion date, 31 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects who have used antibiotics, probiotics or prebiotics within 4 weeks prior to screening.
  • Patients receiving specialized treatment for hyperthyroidism (Graves' disease) or with a history of thyroid malignancy.
  • Patients with active extraintestinal infection requiring treatment with broad-spectrum antibiotics.
  • 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).

Other illness

  • Patients complicated with severe gastrointestinal diseases (e.g., inflammatory bowel disease, active gastrointestinal bleeding).
  • Patients with active severe gastrointestinal bleeding, intestinal perforation, or severe intestinal barrier/mucosal injury.
  • Congenital or acquired immunodeficiency diseases.
  • Patients complicated with other autoimmune diseases.
  • Patients with severe hepatic or renal insufficiency.
  • Patients with malignant tumors.
  • Patients with known allergy to capsule ingredients.

Lab values

  • Patients with severe immunosuppression (neutrophil count \< 1500/mm³, lymphocyte count \< 500/mm³).
  • Severe malnutrition (body mass index \< 15 kg/m²) or severe hypoalbuminemia (serum albumin \< 25 g/L).

Other

  • Patients with intestinal mucosal injury of unknown etiology.
  • Patients diagnosed with fulminant colitis or toxic megacolon.
  • Pregnant or lactating females.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.