Prevalence of FODMAP Intolerance and JHS in FGID and Association With Microbiome, Dyssynergic Defecation and Dietary Intervention

NCT03460613 | Completed

• 1 other identifier: 2016-01887
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

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

  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.

  15 minutes

Secondary Outcomes (2)

• Prevalence of FODMAP intolerance according to nutrient challenge testing (NCT).

  3-4 hours

• Response to dietary intervention

  10-12 weeks

Other Outcomes (2)

• Microbiome in FGID patients

  3-4 weeks

• Prevalence of outlet obstruction in IBS-C subgroup

  1-3 hours

Study Arms (3)

FGID Patients

OTHER

Other: FODMAP diet

Hepatology Control Group

NO INTERVENTION

Healthy Volunteers

NO INTERVENTION

Interventions

FODMAP diet OTHER

Patients with a diagnosed FODMAP intolerance (and a control with no FODMAP intolerance) by prior nutrient challenge testing are going on a FODMAP diet or a 2-food elimination diet (wheat products, milk products excluded). For the FODMAP diet: In a first nutritional visit a specialized nutritionist will inform the patients about FODMAP containing foods and illustrate a FODMAP elimination diet. After 3 weeks of elimination diet another visit will take place and a stepwise reintroduction diet is initiated after successful elimination diet. For the 2-food elemination diet: In a first nutritional visit a specialized nutritionist will inform the patients about the 2-food-elimination diet (foods containing milk- and wheat products) and illustrate an elimination diet. After 3 weeks of elimination diet another visit will take place and a stepwise reintroduction diet is initiated after successful elimination diet.

FGID Patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Functional bowel disease as per physician's diagnosis (medical judgement) and Rome IV criteria
• Signed Informed Consent after being informed
• Age 18-60 years
• Signed Informed Consent after being informed
• Age 18-60 years
• Patient in the ambulatory hepatology clinic
• Signed informed consent after being informed
• Age 18-60 years

You may not qualify if:

• 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
• Previous diagnosed functional gastrointestinal disorders
• Previous diagnosed functional gastrointestinal disorders

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

UniversitätsSpital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Daniel Pohl, PD Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: March 9, 2018
• Study Start: July 7, 2017
• Primary Completion: December 30, 2023
• Study Completion: March 20, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CH (1)