- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00829218
Clinical Trial Examining Effects of Monosodium Glutamate (MSG) on Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97238
- Oregon Health & Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1 - Glutamate challenge
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.
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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.
Other Names:
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Placebo Comparator: 2- Placebo
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.
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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.
Other Names:
Juice with nothing added.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 weeks
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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
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6 weeks, 7 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire
Time Frame: 4 weeks, 7 weeks
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4 weeks, 7 weeks
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Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire
Time Frame: 4 weeks, 7 weeks
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4 weeks, 7 weeks
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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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4 weeks, 7 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Douglas Taren, PhD, University of Arizona
- Principal Investigator: Kathleen F Holton, MPH, PhDc, University of Arizona and Oregon Health & Science Univ.
- Study Director: Kimberly D Jones, PhD, Oregon Health and Science University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Nervous System Diseases
- Disease
- Gastrointestinal Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Fibromyalgia
- Myofascial Pain Syndromes
Other Study ID Numbers
- 4763
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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