Efficacy of Fecal Microbiota Transplantation in Improving Metabolic Parameters and Immune Dysregulation in Patients With Concurrent Type 2 Diabetes Mellitus and Autoimmune Thyroid Disease.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 主要终点
- Thyroid Peroxidase Antibody(TPOAb)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Thyroid Peroxidase Antibody(TPOAb)
时间窗: baseline，week12，week24
Glycated Hemoglobin(HbA1c)
时间窗: baseline，week 12，week 24
Fasting blood glucose
时间窗: baseline，week12，week24
2-hour postprandial blood glucose
时间窗: baseline，week12，week24
Thyroglobulin Antibody(TgAb)
时间窗: baseline，week12，week24
次要结局
- Recovery of characteristic gut microbiota(baseline，week 12，week 24)
- Triglycerides(baseline，week12，week24)
- Total cholesterol(baseline，week12，week24)
- Uric acid(baseline，week12，week24)
- Fasting Insulin(baseline，week12，week24)
- Body weight(baseline，week12，week24)
研究者
Shen Xujun
Deputy Chief Physician
Zhejiang Chinese Medical University