NCT02565550Unknown4 期
Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome
Shandong University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- changes of symptom scores
研究概览
简要总结
To determine the efficacy of a low FODMAP diet in IBS patients and whether gut microbiota community is associated with its efficacy.
详细描述
We seek to determine whether a low FODMAPs diet decreases symptoms in irritable bowel syndrome (IBS)patients and to identify potential microbial factors related to diet efficacy. Pain symptoms, stooling characteristics, breath hydrogen, stool microbiome will be collected and/or documented in IBS patients at baseline and during one week of an low FODMAPs intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the presence of Rome III criteria for IBS ;
- •Patients scheduled for colonoscopy examination or having negative screening examinations
- •Aged between 18 and 65 years old
排除标准
- •Antibiotic, probiotic or laxative usage within 4 weeks.
- •organic gastrointestinal diseases
- •Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
- •pregnancy or lactation.
- •previous major or complicated abdominal surgery.
- •severe endometriosis and dementia
研究组 & 干预措施
IBS patients
Experimental
eat the low FODMAPs diet for one week
干预措施: low FODMAPs (Dietary Supplement)
healthy controls
Active Comparator
eat the low FODMAPs diet for one week
干预措施: low FODMAPs (Dietary Supplement)
结局指标
主要结局
changes of symptom scores
时间窗: 5 months
次要结局
- proportion of responders(3 months)
- quality of life in IBS patients(5 months)
- microbial composition in different response to low FODMAPs(5 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University
研究点 (1)
Loading locations...
相似试验
终止
不适用
Efficacy of a Low FODMAP Diet According to Colonic pH in Irritable Bowel Syndrome PatientsIrritable Bowel SyndromeNCT05326646University Hospital, Rouen24
尚未招募
1 期
Effect of Intensive FMT on Primary HypertensionHypertensionNCT05608447Chinese Academy of Medical Sciences, Fuwai Hospital72
已完成
不适用
Effects of Activia in IBSIrritable Bowel SyndromeNCT01252550Sahlgrenska University Hospital, Sweden100
已完成
不适用
Treatment Efficacy of Low FODMAP Versus Low Lactose Diet in IBS PatientsIBS - Irritable Bowel SyndromeNCT04543474Cantonal Hospital of St. Gallen30
招募中
3 期
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.Irritable Bowel SyndromeNCT05120752Universitair Ziekenhuis Brussel60