NCT02881944

Brief Summary

Fermentable Oligo-, Di and Mono-saccharides And Polyols (FODMAPs) are carbohydrates that are poorly digested in intestines. The undigested carbohydrates are fermented in the colon by gut bacteria. Fermentation of these carbohydrates can lead to diarrhea, gas and distension of the colon. Low FODMAP diet effect may be mediated by changing the gut bacteria and/or by production of chemicals that influence Veteran's intestines which then result in reduced disease symptoms. The goal of this study is to compare a low FODMAP (modified healthy) diet to a high FODMAP (typical healthy) diet for effect on Veterans with IBS and symptoms of Gulf War illness.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

August 24, 2016

Last Update Submit

January 30, 2018

Conditions

Irritable Bowel Syndrome

Keywords

Gulf War IllnessDietIBSFODMAP

Outcome Measures

Primary Outcomes (1)

  • Change in self-reported global Bowel Symptom Score

    Change in bowel symptom score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.

    Baseline and 3 Weeks

Secondary Outcomes (1)

  • Change in self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) score

    Baseline and 3 Weeks

Study Arms (2)

Low FODMAP (modified healthy) Diet

EXPERIMENTAL

Low FODMAP diet for 3 weeks. Veterans will be provided a diet containing foods low in FODMAP.

Behavioral: Low FODMAP Diet

High FODMAP (typical healthy) Diet

EXPERIMENTAL

High FODMAP diet for 3 weeks. Veterans will be provided a typically healthy diet following US Dietary Guidelines, containing foods high in FODMAPs

Behavioral: High FODMAP Diet

Interventions

Low FODMAP DietBEHAVIORAL

Diet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols

Low FODMAP (modified healthy) Diet
High FODMAP DietBEHAVIORAL

Typical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols

High FODMAP (typical healthy) Diet

Eligibility Criteria

Age25 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gulf War Veterans
  • Men and women age 25-90 years
  • Gulf War Illness: Veterans will have Rome III criteria for IBS and two or more of the non-intestinal symptom groups (chronic-once a week or more often-fatigue, insomnia, joint pains, general stiffness, and headache, neurological an mood, respirator and skin symptoms)
  • Symptoms of \> 6 months duration
  • No significant findings on physical examination, complete blood count and clinical chemistry panel

You may not qualify if:

  • Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis.
  • Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease
  • Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction
  • Presence of Giardia antigen, and Clostridium difficile toxin in stool
  • Current history of drug or alcohol abuse
  • Investigator perception of patient's inability to comply with study protocol
  • Recent change in gastrointestinal medications
  • Subject is currently participating in another research protocol. These subjects will be allowed to enroll after a washout period of one month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George E Wahlen VA Medical Center

Salt Lake City, Utah, 84132, United States

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination DietsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ashok K Tuteja, M.D.

    George E. Wahlen VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaya Vijayan, MBBS

CONTACT

801-582-1565jaya.vijayan@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Gastroenterology

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)