Probiotic (Visbiome) for Gulf War Illness
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the bowel symptom scale from the baseline
研究概览
简要总结
The overall objective is to determine whether Visbiome will improve
- intestinal symptoms of Irritable Bowel Syndrome (IBS) and
- non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache) associated with IBS. All of these symptoms are part of the Gulf War (GW) illness.
详细描述
Specific Aims:
Aim # 1: Determine the efficacy of Visbiome on IBS symptoms in GW veterans.
Hypothesis: Treatment with Visbiome compared to placebo will improve global and individual symptoms of IBS
Aim #2 Determine the efficacy Visbiome in reducing non-intestinal symptoms of IBS (fatigue, joint pain, insomnia, general stiffness and headache).
Hypothesis: Treatment with Visbiome compared to placebo will improve non-intestinal symptoms of IBS in GW veterans.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First GW veterans, Men and women age 35-75 years,
- •Rome III criteria for IBS and two or more of the non-intestinal symptoms (chronic-once a week or more often-fatigue, joint pains, insomnia, general stiffness, and headache)
- •Symptoms of > 6 months duration,
- •No significant findings on physical examination, Complete Blood Count (CBC) and clinical chemistry panel.
- •Normal gross appearance of the colonic mucosa other than erythema and polyps
- •Negative Tissue transglutaminase (TTG) for celiac disease,
- •Normal thyroid function.
- •Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis.
- •Stable medication regimen for more than a month
排除标准
- •Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease
- •History of/or presence of systemic malignancy (patients with skin and other cancers in remission for more than 5 years are allowed in the study
- •Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction.
- •Presence of Giardia antigen, and Clostridium difficile toxin in stool,
- •Abnormal blood test for thyroid stimulating hormone, tissue transglutaminase antibody
- •Current effects of drug or alcohol abuse
- •Investigator perception of patient's inability to comply with study protocol
- •Recent change in gastrointestinal medications
- •Use of any antibiotic in the last 1 months
- •Positive pregnancy test
- •Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study.
研究组 & 干预措施
Placebo
Placebo (not an active drug/ Inactive component) is given to this group
干预措施: Placebo (Drug)
Visbiome
Visbiome (probiotic mixture) is given to this group.
干预措施: Visbiome (Drug)
VSL #3
VSL #3 (probiotic mixture) is given to this group
干预措施: VSL#3 (Drug)
结局指标
主要结局
Change in the bowel symptom scale from the baseline
时间窗: Baseline to 8 weeks
Efficacy of Visbiome in IBS related symptoms in GW illness is measured using BSS at 8 weeks
次要结局
- Change in chronic fatigue (1-5 scale) from baseline(baseline to 8 weeks)
研究者
Ashok Tuteja
Professor Gastroenterology
VA Salt Lake City Health Care System