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

Sponsors and Collaborators:	Oregon Health and Science University University of Arizona
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00829218

Purpose

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.

Condition	Intervention
Irritable Bowel Syndrome Fibromyalgia	Other: Glutamate additive-free diet Other: Placebo diet

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety Study
Official Title:	A Clinical Trial Examining the Effects of the Food Additive Glutamate on Irritable Bowel Syndrome and Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Diets Fibromyalgia

Drug Information available for: Glutamic acid

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire [ Time Frame: 4 weeks, 7 weeks ] [ Designated as safety issue: No ]
Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire [ Time Frame: 4 weeks, 7 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 - Glutamate challenge: Active Comparator 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.	Other: Glutamate additive-free diet 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.
2- Placebo: Placebo Comparator 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.	Other: Glutamate additive-free diet 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: Placebo diet Juice with nothing added.

Arms

Assigned Interventions

1 - Glutamate challenge: Active Comparator

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.

Other: Glutamate additive-free diet

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.

2- Placebo: Placebo Comparator

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.

Other: Glutamate additive-free diet

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: Placebo diet

Juice with nothing added.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829218

Contacts

Contact: Kathleen F Holton, MPH, PhDc	503-757-1578	holtonk@ohsu.edu
Contact: Kim D Jones, PhD	503-494-3837	joneskim@ohsu.edu

Locations

United States, Oregon
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97238
Principal Investigator: Kim D Jones, PhD
Sub-Investigator: Kathleen F Holton, MPH, PhDc

Sponsors and Collaborators

Oregon Health and Science University

University of Arizona

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

More Information

No publications provided

Responsible Party:	University of Arizona & Oregon Health & Science University ( Kathleen Holton, MPH, PhD candidate )
Study ID Numbers:	4763
Study First Received:	January 23, 2009
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00829218 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Irritable Bowel Syndrome
Fibromyalgia
Glutamate
Diet
Food additives

Study placed in the following topic categories:

Fibromyalgia
Myofascial Pain Syndromes
Gastrointestinal Diseases
Glutamic Acid
Colonic Diseases
Pain
Rheumatic Diseases

Intestinal Diseases
Muscular Diseases
Digestive System Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Irritable Bowel Syndrome
Colonic Diseases, Functional

Additional relevant MeSH terms:

Disease
Fibromyalgia
Myofascial Pain Syndromes
Gastrointestinal Diseases
Nervous System Diseases
Colonic Diseases
Rheumatic Diseases
Intestinal Diseases

Pathologic Processes
Digestive System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Syndrome
Irritable Bowel Syndrome
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on September 10, 2009