Dietary Treatment for IBS Within Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Proportion of patients with significant symptom reduction
研究概览
简要总结
Irritable bowel syndrome (IBS) is a multifaceted disorder where diet plays a pivotal role in symptom generation and management. The traditional dietary advice given to patients in clinical settings are based on the NICE guidelines. Some of the advice included in these guidelines have limited scientific evidence. The aim of this study is to investigate the effectiveness of the traditional dietary advice in IBS, according to the NICE guidelines, within a primary health care setting, where treatment is delivered digitally and in groups of 8-12 individuals. As a sham comparator, one group will receive dietary advice according to the Swedish dietary guidelines regarding healthy eating habits.
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
- Single (Participant)
盲法说明
Participants will only be told that the both diets aim to relieve symptoms of IBS, and that none of the diets are expected to cure the disorder. No specific names of the diets will be given.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with IBS (ROME IV) by physician
- •Age 18-50
- •Ability to read and understand Swedish
- •Signed informed consent
排除标准
- •Received dietary treatment for IBS previously
- •Manifestations of other conditions that may explain gastrointestinal symptoms
结局指标
主要结局
Proportion of patients with significant symptom reduction
时间窗: From baseline vs. 6 weeks after group session
A responder to treatment is defined as having a symptom reduction \>50 measured by IBS-SSS
次要结局
未报告次要终点
研究者
Magnus Simrén
Professor
Sahlgrenska University Hospital, Sweden