Recruiting

Diet

Sponsor:

Ashok Tuteja

Code:

NCT02881944

Conditions

Irritable Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Low FODMAP Diet

High FODMAP Diet

Study Details

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.

Conditions

Irritable Bowel Syndrome

Study ID

NCT02881944

Start date

Aug, 2016

Status verified date

Jan, 2018

Completion date

Sep, 2018

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Normal gross appearance of the colonic mucosa (small colon polyps not an exclusion criteria)
  • Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low FODMAP (modified healthy) Diet

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

experimental: High FODMAP (typical healthy) Diet

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

Interventions

Low FODMAP Diet

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

High FODMAP Diet

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

Primary outcome measure

  • Change in self-reported global Bowel Symptom Score [ Time Frame: Baseline and 3 Weeks ]

Central Contacts and Locations

Central contacts

Jaya Vijayan, MBBS

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

Locations

George E Wahlen VA Medical Center

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Ashok K Tuteja, MD, MPH

801-582-1565ashok.tuteja@va.gov

Jaya Vijayan

801-581-7802jaya.vijayan@hsc.utah.edu

More Information

Sponsor

Ashok Tuteja

Last update posted

Feb 1, 2018

Last verified

Jan, 2018

Keywords

  • Gulf War Illness
  • Diet
  • IBS
  • FODMAP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ashok Tuteja on 2018-02-01.