search
Back to results

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

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
a low FODMAP diet for 4 weeks
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study patients with IBS-D

Arm Description

Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks

Outcomes

Primary Outcome Measures

Lactulose Mannitol excretion
Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet

Secondary Outcome Measures

Changes in epithelial permeability
Changes in tight junction gene expression, immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet
Changes in stool microbiome
Changes in relative abundance of bacteria before and after low FODMAP diet

Full Information

First Posted
September 1, 2020
Last Updated
August 14, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT04542018
Brief Title
Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
Official Title
Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study patients with IBS-D
Arm Type
Experimental
Arm Description
Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks
Intervention Type
Other
Intervention Name(s)
a low FODMAP diet for 4 weeks
Intervention Description
low FODMAP diet for 4 weeks
Primary Outcome Measure Information:
Title
Lactulose Mannitol excretion
Description
Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in epithelial permeability
Description
Changes in tight junction gene expression, immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet
Time Frame
4 weeks
Title
Changes in stool microbiome
Description
Changes in relative abundance of bacteria before and after low FODMAP diet
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prashant Singh
Phone
734-647-1191
Email
singhpr@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prashant Singh
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prashant Singh
Phone
734-647-1191
Email
singhp@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs