Clinical Trial Examining Effects of Monosodium Glutamate (MSG) on Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM)
- Conditions
- Irritable Bowel SyndromeFibromyalgia
- Interventions
- Other: Glutamate additive-free dietOther: Placebo diet
- Registration Number
- NCT00829218
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- Asthma
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2- Placebo Glutamate additive-free diet Glutamate challenge: After the one month glutamate free diet, subjects will receive 5 grams of glutamate for three days on one week and placebo for three days on the next week. Arm 2 is the placebo arm, which will be juice with nothing added. 1 - Glutamate challenge Glutamate additive-free diet Glutamate challenge: After the one month glutamate free diet, subjects will receive 5 grams of glutamate for three days on one week and placebo for three days on the next week. Arm 1 is the 5 grams of glutamate which will be given in a mixed juice. 2- Placebo Placebo diet Glutamate challenge: After the one month glutamate free diet, subjects will receive 5 grams of glutamate for three days on one week and placebo for three days on the next week. Arm 2 is the placebo arm, which will be juice with nothing added.
- Primary Outcome Measures
Name Time Method To assess whether symptoms return with MSG challenge statistically more frequently than with placebo as measured by symptom scores. 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 4 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States