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

Fibromyalgia Clinical Trial

Official title:

A Clinical Trial Examining the Effects of the Food Additive Glutamate on Irritable Bowel Syndrome and Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829218
• Other study ID #: 4763
• Status: Completed
• Phase: N/A
• First received: January 23, 2009
• Last updated: December 21, 2013
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: December 2013
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fibromyalgia
• Irritable Bowel Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

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.
• Placebo diet
Juice with nothing added.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (1)

Holton KF, Taren DL, Thomson CA, Bennett RM, Jones KD. The effect of dietary glutamate on fibromyalgia and irritable bowel symptoms. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):10-7. Epub 2012 Dec 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	To assess whether symptoms return with MSG challenge statistically more frequently than with placebo as measured by symptom scores.		6 weeks, 7 weeks	No
Secondary	Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire		4 weeks, 7 weeks	No
Secondary	Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire		4 weeks, 7 weeks	No
Secondary	A reduction in pain based on two visual analog scales, one for gut pain, and another for musculo-skeletal pain		4 weeks, 7 weeks	No