Fibromyalgia Clinical Trial
Official title:
A Clinical Trial Examining the Effects of the Food Additive Glutamate on Irritable Bowel Syndrome and Fibromyalgia
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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