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临床试验/NCT02436603
NCT02436603已完成不适用

Integrative Approaches to Managing Irritable Bowel Syndrome (IBS)

Beth Israel Medical Center1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
IBS Quality of Life (IBS-QOL)

研究概览

简要总结

The purpose of this project is to examine whether a low cost, group-oriented integrative medicine approach to irritable bowel syndrome improves participant outcomes. The intervention will combine nutrition counseling on the low FODMAP diet (decreased grains and other disaccharides) and mind-body training with follow-up health coaching.

These participants will be randomized to either a 4-week group-oriented treatment intervention incorporating a low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet and mind-body therapies followed by an 8-week health coaching follow-up period or a waitlist control group. At the end of the 12-week study period, waitlist subjects will be offered the four-week nutrition and mind-body intervention. Over the 12-week study period, we will examine and report on the impact of this treatment intervention on IBS symptoms and quality of life in this population. The investigators will collect data on IBS outcomes as well as on depression and stress.

详细描述

This project will test the effectiveness of an integrative medicine approach in treating irritable bowel syndrome (IBS). Over the course of 18 months, we will recruit 85 participants with IBS in New York City. These participants will be randomized to either a 4-week group-oriented treatment intervention incorporating a low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet and mind-body therapies followed by an 8-week health coaching follow-up period or a waitlist control group. At the end of the 12-week study period, waitlist subjects will be offered the four-week nutrition and mind-body intervention. Over the 12-week study period, we will examine and report on the impact of this treatment intervention on IBS symptoms and quality of life in this population. The investigators will collect data on IBS outcomes as well as on depression and stress.

The hypothesis is that participants will report decreased symptoms and improved function and quality of life as a result of the four-week nutrition and mind-body intervention and 8-week health coaching follow-up period. The goal of this project is to develop a low-cost, effective integrative intervention for IBS, which can be replicated in settings across the U.S.

Objectives The purpose of this project is to examine whether a low cost, group-oriented integrative medicine approach to irritable bowel syndrome improves participant outcomes. The intervention will combine nutrition counseling on the low FODMAP diet and mind-body training with follow-up health coaching.

The hypothesis is that participants will report decreased symptoms as measured by the IBS Symptom Severity Score and improved function and quality of life as a result of the intervention when compared to usual care.

Background Irritable bowel syndrome (IBS) is a chronic debilitating functional gastrointestinal disorder that has a profound effect on the quality of life (QOL) of individuals with IBS. The estimated prevalence of IBS in the general population ranges from 3% to 20%, with most studies estimating that IBS affects 10% to 15% of the general population. Despite its high level of prevalence, the exact causes of IBS are not well understood. Researchers believe that IBS is caused by a wide variety of mental and physical health problems including hypersensitivity, brain-gut signal issues, bacterial gastroenteritis, depression, anxiety, food sensitivity, body chemical imbalances, and/or genetics.

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
None

入排标准

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

入选标准

  • IBS diagnosis> 12 months in duration
  • Over 18 years of age
  • English speaking

排除标准

  • Active major psychiatric illness which would potentially interfere with participation in the study
  • Active eating disorder

结局指标

主要结局

IBS Quality of Life (IBS-QOL)

时间窗: Baseline and Week 12

Change in IBS-QOL at week 12 as compared to Baseline

IBS Symptom Severity Scale

时间窗: Baseline and week 12

a validated tool which is currently the gold standard for evaluating interventions for IBS. Change in IBS Symptom Severity Scale at week 12 as compared to Baseline

次要结局

  • Patient Global Impression of Change (PGIC)(Baseline and Week 12)
  • Perceived Stress Scale (PSS)(Baseline and Week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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