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临床试验/NCT05831306
NCT05831306招募中不适用

A Randomized Clinical Trial Evaluating Two Different Diets for IBS

Beth Israel Deaconess Medical Center4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
4
主要终点
Abdominal Pain Intensity

研究概览

简要总结

Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.

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
Triple (Participant, Care Provider, Investigator)

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Abdominal Pain Intensity

时间窗: 28 days

Proportion of weekly responders. A weekly responder is defined as a decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline.

次要结局

  • Abdominal Discomfort Intensity(28 days)
  • Abdominal Bloating Intensity(28 days)
  • Adequate Relief(28 days)
  • Composite Score(28 days)
  • Stool Consistency(28 days)
  • Irritable Bowel Syndrome - Symptom Severity Score(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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