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Completed

NCT Number: NCT00829218

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Fibromyalgia Gastrointestinal Diseases Intestinal Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97238, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glutamate additive-free diet

Other

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: Glutamate will be used as a challenge in the form of MSG.

Placebo diet

Other

Juice with nothing added.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire

    Time frame: 4 weeks, 7 weeks

  2. Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire

    Time frame: 4 weeks, 7 weeks

  3. 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • University of Arizona

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jan 26, 2009
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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