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Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT04542018
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Prashant Singh, University of Michigan

Study Description
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Brief Summary:
This research is studying whether changing an individual's diet may have an impact as a treatment or outcome for Irritable Bowel Syndrome (IBS). This research will show if diet might play a role in triggering changes that may cause IBS. This study is being done to learn if a low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diet causes changes in the colon lining which mediates improvement in IBS symptoms.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: a low FODMAP diet for 4 weeks Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with diarrhea predominant IBS (IBS-D) will undergo 4 weeks of low FODMAP diet. Urine, blood, stool, and colon biopsies will be collected before and after the diet to assess changes in gut physiology.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study patients with IBS-D
Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks
 Other: a low FODMAP diet for 4 weeks
low FODMAP diet for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Lactulose Mannitol excretion [ Time Frame: 4 weeks ]
    Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet


Secondary Outcome Measures :
  1. Changes in epithelial permeability [ Time Frame: 4 weeks ]
    Changes in tight junction gene expression, immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet

  2. Changes in stool microbiome [ Time Frame: 4 weeks ]
    Changes in relative abundance of bacteria before and after low FODMAP diet


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein or fecal calprotectin, complete blood count since the onset of symptoms.
  • Normal stool studies including, ova and parasites since the onset of symptoms
  • IBS-SSS score of ≥175 at the end of the 7-day screening period

In case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.

Exclusion criteria

  • individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
  • individuals with any known food allergy or insulin-dependent diabetes
  • known history of celiac disease, inflammatory bowel disease or microscopic colitis
  • prior small bowel or colonic surgery or cholecystectomy
  • pregnant patients
  • Antibiotics in the past 3 months
  • Those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.
Contacts and Locations
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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): NCT04542018


Contacts
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Contact: Prashant Singh 734-647-1191 singhpr@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Prashant Singh    734-647-1191    singhp@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Prashant Singh University of Michigan
More Information
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Responsible Party: Prashant Singh, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04542018    
Other Study ID Numbers: HUM00166423
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
 Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases