跳至主要内容
临床试验/NCT03460613
NCT03460613已完成不适用

Prevalence of FODMAP Intolerance and Joint Hypermobility Syndrome in Functional Bowel Patients and Association With Microbiome, Dyssynergic Defecation and Dietary Intervention - a Prospective Cohort Study With Health-related Intervention

University of Zurich2 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2017年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
498
试验地点
2
主要终点
Prevalence of Joint Hypermobility / hypermobile Ehlers-Danlos Syndrome according to the criteria of the "2017 International Classification of the Ehlers-Danlos Syndromes" (hEDS)

研究概览

简要总结

Irritable bowel syndrome (IBS) is a disorder of gastrointestinal function characterized by abdominal symptoms and pain associated with alterations in bowel habit. The condition impacts on the quality of life of at least 10% of the population, impacts on activities of daily living and is associated with considerable direct and indirect costs to the individual, the health system and society. The etiology of IBS appears multifactorial and several mechanisms, among them mucosal inflammation, abnormal intestinal motility, visceral hypersensitivity and psychological factors, appear to be involved.

An underlying pathophysiology, namely Joint Hypermobility (JH) and Joint Hypermobility Syndrome (JHS), that we are going to study, have recently gained increasing attention in patients with functional bowel disease.

One factor which was shown in previous IBS-studies to reduce abdominal symptoms is a FODMAP diet.

To identify FGID patients which profit most from different diagnostics and therapies (such as dietary intervention (FODMAP diet, 2-food-elimination diet)) we are going to carry out a study analyzing different subtypes of FGID (in particular IBS, FD, functional abdominal pain/bloating) for demographics, clinical diagnostics (e.g. nutrient challenge testing, microbiome testing, anorectal manometry and MR defecography), comorbidities (in particular JH, JHS and psychological comorbidities) and treatment.

详细描述

Functional gastrointestinal disorders (FGID) are common in the general population. Symptoms such as pain, nausea, bloating, diarrhea or constipation may occur. Irritable bowel syndrome (IBS) is the most common FGID with a prevalence in the range of 5-25%. Medical attention is sought by 20-75% of patients who meet diagnostic criteria for IBS at some time in their lives. Quality of life is often impaired in IBS patients. In previous studies a diet low in FODMAP was shown to reduce gastrointestinal symptoms in IBS patients.

But still it is unknown which FGID patients (e.g. patients with irritable bowel syndrome, functional dyspepsia (FD), functional abdominal pain/bloating) profit most from such a diet which involves costs, time and significant lifestyle alteration.

To test for food intolerances, standard hydrogen breath tests using fructose or lactose as challenge substance are still commonly used and do present a nutritional challenge, however the usefulness of information gained is questionable. Fructose intolerance is as prevalent in IBS as in healthy volunteers, in fact when tested with the usual doses of 25-50g, prevalence of fructose intolerance ranges between 53% and 73%. Testing (genetic) for hypolactasia, is often, even in the professional setting, misunderstood as lactose intolerance testing. Most patients, who do have hypolactasia, i.e. almost no activity of intestinal brush-border enzyme lactase, tolerate up to 12g of lactose per day, remain asymptomatic and therefore should not be considered lactose intolerant. In addition, one must realize, that the vast majority in the world is hypolactasic and hypolactasia, or rather lactase persistence, constitutes a norm variant.

Recently it was shown that a standardized liquid mixed nutrient meal including 25g lactulose, but not with 15g lactulose, allows differentiation of IBS patients from healthy controls. This test, incorporating FODMAP lactulose, that, unlike lactose and fructose, is indigestible in all humans in the small intestine, plus a caloric load, reflecting a regular meal and everyday life, has therefore the potential to be a useful marker of nutrient intolerance in patients with suspected functional bowel disease.

Additionally, associations between FGID and JH/JHS have been recognized in the past decade. JH/JHS constitutes a hereditary disorder of connective tissue in which patients often report non-musculoskeletal symptoms, among them gastrointestinal complaints. Previous studies in Europe and the U.S. have reported a JHS prevalence of 20% in the general population.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(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

研究组 & 干预措施

FGID Patients

Other

干预措施: FODMAP diet (Other)

Hepatology Control Group

No Intervention

Healthy Volunteers

No Intervention

结局指标

主要结局

Prevalence of Joint Hypermobility / hypermobile Ehlers-Danlos Syndrome according to the criteria of the "2017 International Classification of the Ehlers-Danlos Syndromes" (hEDS)

时间窗: 15 minutes

Prevalence of joint hypermobility resp. hEDS will be assessed by physicians according to the criteria of the "2017 International Classification of the Ehlers-Danlos Syndromes" in patients with disorders of gut-brain interactions (FGID). The assessment consists of some hypermobility testings (wrists, fingers, elbows, knees and legs) and questions about family hypermobility syndrome history, scars healing, hernia history etc.

次要结局

  • Prevalence of FODMAP intolerance according to nutrient challenge testing (NCT).(3-4 hours)
  • Response to dietary intervention(10-12 weeks)
  • Prevalence of FODMAP intolerance according to nutrient challenge testing (NCT).(3-4 hours)
  • Response to dietary intervention(10-12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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