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Effects of Low FODMAP Diet on Leaky Gut

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FODMAP diet
Sponsored by
Beth Israel Deaconess Medical Center
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:

  • aged 18-65 years at the time of screening
  • normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms
  • normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms
  • IBS-SSS score of ≥175 at the end of 7-day screening period

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 CenterRecruiting
  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FODMAP diet

Arm Description

Outcomes

Primary Outcome Measures

colonic permeability
Lactulose:Mannitol ratio pre and post treatment

Secondary Outcome Measures

colonic immune cells
expression of tight junction proteins pre and post treatment using RT-PCR
colonic microbiome
relative stool microbial abundance pre and post treatment measured using 16s RNA

Full Information

First Posted
August 5, 2020
Last Updated
August 24, 2020
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04526808
Brief Title
Effects of Low FODMAP Diet on Leaky Gut
Official Title
Effects of Low FODMAP Diet on Leaky Gut and Mucosal Immune Cell Abundance in Diarrhea-predominant Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

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
The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.

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
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FODMAP diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
FODMAP diet
Intervention Description
low FODMAP diet
Primary Outcome Measure Information:
Title
colonic permeability
Description
Lactulose:Mannitol ratio pre and post treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
colonic immune cells
Description
expression of tight junction proteins pre and post treatment using RT-PCR
Time Frame
4 weeks
Title
colonic microbiome
Description
relative stool microbial abundance pre and post treatment measured using 16s RNA
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: aged 18-65 years at the time of screening normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms IBS-SSS score of ≥175 at the end of 7-day screening period 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
Vivian Cheng
Phone
617.667.0682
Email
vcheng2@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Lembo, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Cheng
Phone
617-667-0682
Email
vcheng2@bidmc.harvard.edu
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, MD
Email
singhpr@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Low FODMAP Diet on Leaky Gut

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