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临床试验/NCT03760133
NCT03760133已完成2 期

The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics: Randomized Controlled, Open-label Trial

Kosin University Gospel Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
1
主要终点
The effect of probiotics on the change of gut microbiota after bowel preparation.

研究概览

简要总结

The purpose of this study is to investigate the relationship between the change of intestinal bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort after colonoscopy. And the investigators will also analyze the effects of probiotics on the degree of change, recovery, and symptom development in intestinal flora.

详细描述

The investigators divided two groups. (total number = 100 subjects)

  1. with probiotics group - 50 subjects
  • Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
  1. without probiotics group - 50 subjects
  • Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults between the age of 30 and 70

排除标准

  • subjects with cancer or IBD (inflammatory bowel disease)
  • subjects with history of abdominal surgery
  • subjects who take medication related to gastrointestinal motility within 3 months
  • subjects who take antibiotics within 3 months

研究组 & 干预措施

with Probiotics

Active Comparator

Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.

干预措施: Duolac (Drug)

结局指标

主要结局

The effect of probiotics on the change of gut microbiota after bowel preparation.

时间窗: eight months

Analysis the change of gut microbiota before and after bowel preparation for colonoscopy, and the effect of probiotics.

次要结局

  • The correlation between symptoms and gut microbiota..(eight months)
  • The occurrence of symptoms(eight months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jae Hyun Kim

Assistant Professor

Kosin University Gospel Hospital

研究点 (1)

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