Irritable Bowel Syndrome, Fibromyalgia
Conditions
Keywords
Irritable Bowel Syndrome, Fibromyalgia, Glutamate, Diet, Food additives
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.
Interventions
OTHERGlutamate 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.
OTHERPlacebo diet
Juice with nothing added.
Sponsors
University of Arizona
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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 | 4 weeks |
| To assess whether symptoms return with MSG challenge statistically more frequently than with placebo as measured by symptom scores. | 6 weeks, 7 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed