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
About this trial
This is an interventional basic science trial for Irritable Bowel Syndrome
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.
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
NCT ID
NCT04542018
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)
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