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

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ClinicalTrials.gov Identifier: NCT03460613
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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 FODMAP 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.


Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorders Other: FODMAP diet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
FGID Patients 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. 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.

No Intervention: Hepatology Control Group
No Intervention: Healthy Volunteers



Primary Outcome Measures :
  1. Prevalence of Joint Hypermobility / hypermobile Ehlers-Danlos Syndrome according to the criteria of the "2017 International Classification of the Ehlers-Danlos Syndromes" (hEDS) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Prevalence of FODMAP intolerance according to nutrient challenge testing (NCT). [ Time Frame: 3-4 hours ]
    Prevalence of FODMAP intolerance in FGID patients will be assessed according to nutrient challenge testing (NCT). Patients drink a specific beverage containing a specific sugar. The hydrogen value in breath is then measured every 10 minutes and symptoms are recorded at the same time. Depending on the time of hydrogen production and the increase of abdominal symptoms can a FODMAP intolerance be determined.

  2. Response to dietary intervention [ Time Frame: 10-12 weeks ]
    FGID patients will be randomized according to the participants JH-status and according to the result of NCT to the dietary intervention. They will follow a specific intervention diet with guidance of a dietician and the abdominal symptoms will be assessed every 4 weeks approximately.


Other Outcome Measures:
  1. Microbiome in FGID patients [ Time Frame: 3-4 weeks ]
    Microbiome changes after dietary intervention will be analyzed.

  2. Prevalence of outlet obstruction in IBS-C subgroup [ Time Frame: 1-3 hours ]
    Prevalence of outlet obstruction in a subgroup of FGID patients (IBS-C) will be analyzed by high resolution anorectal manometry and/or MR defecography



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria 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

Exclusion criteria 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460613


Contacts
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Contact: Daniel Pohl, PD Dr. med. +41442551111 daniel.pohl@usz.ch

Locations
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Switzerland
UniversitätsSpital Recruiting
Zürich, Switzerland, 8091
Contact: Daniel Pohl         
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Daniel Pohl, PD Dr. med. University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03460613     History of Changes
Other Study ID Numbers: 2016-01887
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases