Improved Cancer Recovery Leveraging The Microbiom (With Personalized Prebiotics)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in gut microbiota composition and identification of bacterial signatures associated with cancer treatment.
研究概览
简要总结
This is a two-phase clinical study evaluating changes in the gut microbiota of cancer patients undergoing standard cancer treatment and the impact of microbiome-based interventions on recovery. Phase I is a prospective, single-arm observational study assessing gut microbiota composition before treatment, post-treatment, and up to 2 months after treatment to identify microbial signatures and dysbiosis associated with cancer therapy.Phase II is an interventional study evaluating the effect of personalised prebiotic and nutritional interventions on gut microbiota, assessed before intervention and after 2 months of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Condition: Diagnosed with Upper GI cancer (for patient group).
- •BMI: 18–29.9 kg/m².
- •Other: Willingness to provide stool samples and provide informed consent.
排除标准
- •Chronic illnesses requiring hospitalization or known GI disorders.
- •Major surgery/hospitalization in the last 6 months.
- •Long-term antibiotic/anti-tubercular treatment.
- •COVID-19 infection within the last 3 months.
结局指标
主要结局
Changes in gut microbiota composition and identification of bacterial signatures associated with cancer treatment.
时间窗: Baseline (Day 1), Post-treatment (Day 60), Follow-up (Day 90–150)
次要结局
- Changes in microbial diversity, correlation with clinical and demographic variables, and patient-reported wellness outcomes (sleep, fatigue, stress).(Baseline, 8 weeks post-intervention.)
研究者
Dr Rajeev Kumar
Cachar Cancer Hospital and Research Centre