Irritable Bowel Syndrome
Conditions
Keywords
Gulf War Illness, Diet, IBS, FODMAP
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.
Detailed 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.
Interventions
BEHAVIORALLow FODMAP Diet
Diet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
BEHAVIORALHigh FODMAP Diet
Typical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
Sponsors
United States Department of Defense
Ashok Tuteja
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported global Bowel Symptom Score | Baseline and 3 Weeks | Change in bowel symptom score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) score | Baseline and 3 Weeks | Change in IBS-QOL score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet. |
Countries
United States
Contacts
Primary ContactJaya Vijayan, MBBS
Outcome results
None listed