NCT06612411招募中早期 1 期
Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome
Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The score of IBS-SSS before and after intervention
研究概览
简要总结
This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Participants with IBS are recruited and randomized to receive a 4-week administration of B. subtilis-based probiotics. Clinical symptoms and stool samples are collected before and after the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are diagnosed with IBS. IBS was diagnosed based on the Rome IV criteria. Subjects aged from 16-80 years old without any gut medical conditions like inflammatory bowel diseases, infectious diarrhea, colon tumors were included.
排除标准
- •Subjects who are taking any probiotics, PPIs, antibiotics or any drugs affecting uric acid levels for at least one month before the study.
- •Subjects who decline to participate into the study.
研究组 & 干预措施
B. subtilis intervention
Active Comparator
干预措施: B. subtilis (Drug)
Placebo capsules
Placebo Comparator
干预措施: Dead B. subtilis (Drug)
结局指标
主要结局
The score of IBS-SSS before and after intervention
时间窗: 6 months
次要结局
- The concentration of purine in the stool before and after intervention(6 months)
研究者
Fangyu Wang
Professor
Jinling Hospital, China
研究点 (1)
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