Clinical Trial Examining Effects of Monosodium Glutamate (MSG) on Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM)

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Fibromyalgia

• 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

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Primary Completion: 2009-11
• Study Completion: 2010-05
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-21
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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