Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the impact of bowel preparation on the gut microbiota at 1 week after bowel preparation.
研究概览
简要总结
The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota.
详细描述
Based on the limited literature that PEG does not significantly impact the microbiome, certain investigators ascertain that administration of PEG without any subsequent FMT would represents the gold-standard control group. On the other hand, other investigators raised their concern that perturbation of the microbiome with PEG without subsequent replacement with FMT might negatively impact immune checkpoint inhibitor efficacy. Therefore, there is an unmet need to conduct a study using the metagenomic shotgun sequencing to precisely understand the impact of bowel preparation on gut microbiome composition and on the dynamics of recovery of the gut microbiome after bowel preparation to better design microbiome-centered trials.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer participant cohort:
- •> 18 years of age
- •The participant has provided documented informed consent for the participation and to complete PEG bowel preparation and return collected stool samples.
排除标准
- •Significant gastric retention
- •Suspected or established mechanical bowel obstruction
- •Inflammatory or infectious gastrointestinal condition
- •Neurologic or cognitive impairment that prevents safe swallowing
- •Recent history (<1 year) of cancer that still requires ongoing treatment
- •Recent use of antibiotics 1 month prior to participation in the trial
- •History of cardiac disease
- •History of active renal dysfunction
- •Presence of any absolute contraindication to PEG bowel preparation according to manufacturer labeling
研究组 & 干预措施
Healthy volunteer participant cohort
For healthy volunteer participants, PEG bowel preparation will be administered and participants will collect stool samples before and after PEG at specified timepoints.
干预措施: PEGLyte bowel preparation (Drug)
结局指标
主要结局
To evaluate the impact of bowel preparation on the gut microbiota at 1 week after bowel preparation.
时间窗: At week 1
Study of the gut microbiota composition at 1 week after bowel preparation.
次要结局
- Gut microbiome composition, diversity, and gut metabolome profile at 1 month and 3 months after bowel preparation(At 1 month and 3 months)