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

ConditionsAutoimmune Thyroid DiseaseType 2 Diabetes Mellitus (T2DM)FMT
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Fecal microbiota transplantation oral capsules

    Biological/Vaccine

    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).

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Fecal microbiota transplantation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Glycated Hemoglobin(HbA1c)

Time frame
baseline，week 12，week 24
2

Fasting blood glucose

Time frame
baseline，week12，week24
3

2-hour postprandial blood glucose

Time frame
baseline，week12，week24
4

Thyroid Peroxidase Antibody(TPOAb)

Time frame
baseline，week12，week24

Secondary outcomes

1

Recovery of characteristic gut microbiota

Time frame
baseline，week 12，week 24
2

Triglycerides

Time frame
baseline，week12，week24
3

Total cholesterol

Time frame
baseline，week12，week24
4

Uric acid

Time frame
baseline，week12，week24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shen Xujun

Lead sponsor

Zhejiang Chinese Medical University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: