Effect of Diet on Gulf War Illness

Irritable Bowel Syndrome Clinical Trial

Official title:

Effect of Diet on Gulf War Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02881944
• Other study ID #: IRB_00087668
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2016
• Last updated: January 30, 2018
• Start date: August 2016
• Est. completion date: September 2018

Study information

• Verified date: January 2018
• Source: VA Salt Lake City Health Care System
• Contact: Jaya Vijayan, MBBS
• Phone: 801-582-1565
• Email: jaya.vijayan[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Design This will be a prospective, blinded randomized clinical trial with two parallel groups. There will be 1-week screening period, 3-week diet treatment and, follow-up one month later while Veterans choose their own diet.

Veterans who were deployed and served in Operation Desert Storm and Desert Shield will be recruited to participate.

The two study diets to be provided to the Veterans and compared are:

Low FODMAP (modified healthy) diet:

High FODMAP (typical healthy) diet:

The FODMAP content of this diet will be higher than low FODMAP diet.

All questionnaires will be answered and measurements performed at baseline, end of treatment and at follow-up visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	George E Wahlen VA Medical Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Ashok Tuteja	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) score	Change in IBS-QOL score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.	Baseline and 3 Weeks