Fecal Microbiota Transplantation for Type 2 Diabetes Mellitus and Hashimoto's Thyroiditis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShen Xujun
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Fecal microbiota transplantation oral capsules
Treatment groups
38 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Shen Xujun
Lead sponsor
Zhejiang Chinese Medical University
Sponsor institution
Source ClinicalTrials.gov