A Clinical Trial Examining the Effects of the Food Additive Glutamate on Irritable Bowel Syndrome and Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To assess whether symptoms return with MSG challenge statistically more frequently than with placebo as measured by symptom scores.
研究概览
简要总结
Objective: Randomized, double blind, placebo-controlled, crossover, clinical trial to examine the effects of the food additive glutamate (in the form of MSG) on IBS and fibromyalgia.
Setting and Subjects: The Fibromyalgia Research Database at OHSU will be utilized to identify and recruit fibromyalgia patients who also have IBS to OHSU study centers.
Intervention: Approximately 60 male and female subjects aged 18-75 will be placed on a 1-month glutamate-free elimination diet. Those that respond positively to the diet (we are estimating 30-40 subjects), will then be randomized to receive either a citrus drink containing 5 grams of MSG; or placebo (the citrus drink alone)on three consecutive days one week apart.
The investigators are hypothesizing that those who react positively to the elimination diet will have symptom occurrence statistically more frequently when given the glutamate challenge, than when given placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-75 who fulfill criteria for Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM)
- •They must live in the greater Portland, OR, metro area, have transportation to/from study site, have access to email
- •Willing to discontinue medications with bowel altering side effects
排除标准
- •Inflammatory bowel disease
- •Colon cancer or active endometriosis
- •Any major abdominal surgery (excluding caesarean section, tubal ligation, hernia repair, gall bladder removal or appendectomy)
- •Female and pregnant
- •Currently taking pregabalin, gabapentin, or anti-psychotic medications and are unwilling/ unable to discontinue use
- •Suffered from alcohol/substance abuse or psychosis in the last two years.
结局指标
主要结局
To assess whether symptoms return with MSG challenge statistically more frequently than with placebo as measured by symptom scores.
时间窗: 6 weeks, 7 weeks
To evaluate the number of patients who have a positive response to a one month glutamate free diet, as measured by the Perception of Global Impression of Change (PGIC) scores
时间窗: 4 weeks
次要结局
- Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire(4 weeks, 7 weeks)
- Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire(4 weeks, 7 weeks)
- A reduction in pain based on two visual analog scales, one for gut pain, and another for musculo-skeletal pain(4 weeks, 7 weeks)
研究者
Kathleen F. Holton
Research Assistant Professor
Oregon Health and Science University