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

NCT03460613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2025-12-02

No results posted yet for this study

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

Interventions

OTHER

FODMAP diet

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.

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Daniel Pohl, PD Dr. med. · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2023-12-30
Completion
2024-03-20

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03460613 on ClinicalTrials.gov