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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 498
- 试验地点
- 1
- 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
- 是
入选标准
- •for FGID patients:
- •Functional bowel disease as per physician's diagnosis (medical judgement) and Rome IV criteria
- •Signed Informed Consent after being informed
- •Age 18-60 years
- •Inclusion criteria for hepatology control cohort:
- •Signed Informed Consent after being informed
- •Age 18-60 years
- •Patient in the ambulatory hepatology clinic
- •Inclusion criteria for healthy volunteers:
- •Signed informed consent after being informed
- •Age 18-60 years
排除标准
- •for FGID patients:
- •Inflammatory bowel disease
- •Gastrointestinal malignancy
- •Celiac Disease
- •Known or suspected non-compliance, drug or alcohol abuse
- •Previous large abdominal surgery likely to impact patient symptomatology
- •Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc. of the participant
- •Previous enrollment into the current study
- •Use of antibiotics in the previous 4 weeks before enrolment
- •Exclusion criteria for hepatology control cohort:
- •Previous diagnosed functional gastrointestinal disorders
- •Exclusion criteria for healthy volunteers:
- •Previous diagnosed functional gastrointestinal disorders
研究组 & 干预措施
FGID Patients
干预措施: FODMAP diet (Other)
Hepatology Control Group
Healthy Volunteers
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)
