Effect of Diet on Gulf War Illness
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in self-reported global Bowel Symptom Score
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in self-reported global Bowel Symptom Score
时间窗: Baseline and 3 Weeks
Change in bowel symptom score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.
次要结局
- Change in self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) score(Baseline and 3 Weeks)
研究者
Ashok Tuteja
Professor Gastroenterology
VA Salt Lake City Health Care System