Effect of Diet on Gulf War Illness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Diet on Gulf War Illness

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Low FODMAP Diet
* Behavioral: High FODMAP Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low FODMAP (modified healthy) Diet<br>Low FODMAP diet for 3 weeks. Veterans will be provided a diet containing foods low in FODMAP. | Behavioral: Low FODMAP Diet<br>* Diet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols<br>|
| Experimental: High FODMAP (typical healthy) Diet<br>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<br>* Typical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gulf War Illness, Diet, IBS, FODMAP