Investigating the Role of Fecal Microbiota Transplantation in Immune and Metabolic Alterations in Type 1 Diabetes: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
This randomized controlled trial aims to evaluate the impact of faecal microbiota transplantation on gut microbial diversity, microbial metabolites, immune modulation, and glycemic control in patients with Type 1 Diabetes. Participants with recent-onset T1D (less than or equal to 5 years, with detectable C-peptide) will be randomized to receive either allogenic FMT (from healthy donors) or autologous FMT (own stool). The intervention will be followed over 12 months.
Key endpoints include changes in gut microbiota composition, stool short-chain fatty acids (SCFAs), frequency of regulatory T cells, cytokine levels, HbA1c, and C-peptide. The study will use multi-omics integration of microbiome, metabolomics, and immunological data to understand how FMT can potentially preserve beta-cell function and modulate autoimmune progression in T1D. This is the first trial in India to explore immunological endpoints of FMT in T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with T1D duration less than 5 years with detectable C-peptide level No antibiotic use in the last 3 months No history of gastrointestinal diseases or recent infections.
排除标准
- •Inability to provide written informed consent Evidence for absent residual beta cell function undetectable C-peptide Antibiotics use in the last 3 months and proton pump inhibitor use Presence of other autoimmune disorders Use of immunosuppressive medications Pregnancy or with a pregnancy plan Severe diabetic complications or active infections severe organ dysfunction (including decompensated cirrhosis, malignant tumors etc.) History of any probiotic supplement drug and no history of any probiotic supplement drug intake in last 8 weeks.
研究者
Priyam Batra
All India Institute of Medical Sciences