Exploring the role of human gut microbiome and metabolites in ulcerative colitis: an approach towards clinical implications and precision medicine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Microbial diversity and richness (e.g., Shannon index, alpha-diversity, beta-diversity)
研究概览
简要总结
This is a prospective observational study designed to understand how gut bacteria and body chemicals influence ulcerative colitis in the Indian population. Ulcerative colitis is a long term inflammatory disease of the colon that causes symptoms such as abdominal pain, diarrhea, and bleeding. The study will compare the gut microbiome and metabolite profiles of patients with ulcerative colitis and healthy individuals to identify specific bacterial and metabolic changes linked to the disease.
About 200 participants will be included, 100 with ulcerative colitis and 100 healthy controls matched for age and sex. Stool, blood, and biopsy samples will be collected for analysis. The study will also include a smaller follow up group of ulcerative colitis patients to observe changes over time. The samples will be processed using advanced genomic and metabolomic techniques to identify differences in gut microbes, metabolites, and genetic markers.
This research does not involve any new drug or device. Participants will continue their routine medical care as advised by their treating doctors. All data will be coded to maintain confidentiality. The information gained from this study may help in understanding disease mechanisms, identifying early biomarkers, and guiding the development of personalized or microbiome based treatment strategies for ulcerative colitis in the future.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult participants diagnosed with ulcerative colitis based on clinical criteria, including colonoscopy and histopathological confirmation.
- •UC patients at different disease stages (newly diagnosed, active, and in remission).
- •Age- and gender-matched healthy controls for comparison.
排除标准
- •History of other gastrointestinal diseases.
- •Recent use (within the last 6 months) of Antibiotics, Anti-diabetic drugs or Immunosuppressive treatments.
结局指标
主要结局
Microbial diversity and richness (e.g., Shannon index, alpha-diversity, beta-diversity)
时间窗: At baseline, fecal, blood, and tissue samples from ulcerative colitis patients and healthy controls will be analyzed for gut microbial diversity, genetic mutations, and metabolite profiles. At 6 months, repeat samples from ulcerative colitis patients will assess temporal changes. At 12 months, follow up will evaluate stability or progression of dysbiosis and metabolomic changes.
Metabolomic profile differences between UC and healthy individuals.
时间窗: At baseline, fecal, blood, and tissue samples from ulcerative colitis patients and healthy controls will be analyzed for gut microbial diversity, genetic mutations, and metabolite profiles. At 6 months, repeat samples from ulcerative colitis patients will assess temporal changes. At 12 months, follow up will evaluate stability or progression of dysbiosis and metabolomic changes.
Presence and frequency of genetic mutations correlated with gut dysbiosis.
时间窗: At baseline, fecal, blood, and tissue samples from ulcerative colitis patients and healthy controls will be analyzed for gut microbial diversity, genetic mutations, and metabolite profiles. At 6 months, repeat samples from ulcerative colitis patients will assess temporal changes. At 12 months, follow up will evaluate stability or progression of dysbiosis and metabolomic changes.
次要结局
- Correlation between specific gene mutations & changes in microbiome composition.(Identification of metabolite biomarkers linked to disease severity.)
研究者
Shiran Shetty
Manipal Academy of Higher Education