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

University of Michigan2 sites in 1 country48 target enrollmentAugust 3, 2020

ConditionsIrritable Bowel Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Irritable Bowel Syndrome
Sponsor: University of Michigan
Enrollment: 48
Locations: 2
Primary Endpoint: Lactulose Mannitol Excretion
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 3, 2020

End Date

May 15, 2024

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Prashant Singh

Assistant Professor

University of Michigan

Eligibility 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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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 measured during 8-24h

Secondary Outcomes

Changes in Stool Microbiome - Alpha Diversity(4 weeks)
Immunohistochemistry for Mast Cells(4 weeks)
Changes in Epithelial Permeability - Tight Junction Gene Expression(4 weeks)
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining(4 weeks)
Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)(4 weeks)
Changes in Stool Microbiome - Beta Diversity(4 weeks)