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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
All subjects will follow a diet for one month where all foods containing the additive glutamate have been removed. At the end of the one month diet, subjects who have responded positively to the diet will go onto the challenge arms of the study, where they will be randomized to receive placebo (mixed juice alone) for three days on one week, and 5 grams of glutamate in the mixed juice for three days on the other week.
Juice with nothing added.
Oregon Health & Science University
Portland, Oregon, United States
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
Time frame: 4 weeks
To assess whether symptoms return with MSG challenge statistically more frequently than with placebo as measured by symptom scores.
Time frame: 6 weeks, 7 weeks
Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire
Time frame: 4 weeks, 7 weeks
Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire
Time frame: 4 weeks, 7 weeks
A reduction in pain based on two visual analog scales, one for gut pain, and another for musculo-skeletal pain
Time frame: 4 weeks, 7 weeks
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