The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- IBS quality of life score
研究概览
简要总结
Treatment of IBS is very problematic. Despite the wide range of pharmacological and non-pharmacological therapies, there is no universally accepted approach. In recent years, the low FODMAP diet has been developed, a dietary approach that aims to relieve the symptoms of IBS. FODMAPs (Fermentable Oligosaccharides, Di-saccharides, Mono-saccharides and Polyols) are a group of dietary sugars that may be poorly absorbed in the small intestine and fermented by bacteria to produce gas. Ingestion of FODMAPs may also result in alterations in fluid content in the colon and trigger functional gut symptoms in some individuals. This study aims to examine the effectiveness of the FODMAP diet in Israel in improving symptoms of IBS compared to the standard dietary advice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfillment of the Rome III criteria for IBS.
- •Aged 18-77 years at the time of screening.
- •Provision of written informed consent.
- •Commitment of availability throughout the 10 week study period.
- •Availability of at least one GI imaging study during the last 5 years (colonoscopy, sigmoidosopy, abdominal ultrasonography, barium enema) for subjects older than 50 years.
排除标准
- •Major abdominal surgery in the past.
- •The presence of any active (organic) GI disease.
- •Past or present major medical or psychiatric illness.
- •Any concomitant disease.
- •Alarming symptoms (rectal bleeding, weight loss, etc.)
- •Family history of colorectal carcinoma or IBD, under the age of
- •Abnormal laboratory studies (blood biochemistry, liver enzymes, complete blood count), abnormal thyroid function.
- •Non-adjusted diet in the case of lactose or gluten intolerance.
- •Recent travel to regions with endemic parasitic diseases.
结局指标
主要结局
IBS quality of life score
时间窗: 9 weeks
Irritable Bowel Syndrome (IBS) severity score
时间窗: 9 weeks
次要结局
未报告次要终点