Irritable Bowel Syndrome and Food Sensitivity

Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways

The primary objective of the clinical trial portion of this study is to assess whether an individualized dietary plan based on a commercial food sensitivity assay provides specific benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).

This is a parallel group, randomized control trial, powered to assess changes in validated outcomes in adult patients with symptomatic irritable bowel syndrome. Subjects will receive dietary counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments will occur at baseline, 4-weeks, and 8-weeks post-baseline.

Inclusion Criteria:

• Between 18-70 years of age.
• Irritable Bowel Syndrome by Rome III criteria.
• Stable dose (30 days) of concurrent IBS medications
• Agree not to make significant changes to their diet during the study
• IBS-SSS score of >150

Exclusion Criteria:

• History of major abdominal surgeries
• History of inflammatory bowel disease
• Antibiotic use within 1 month of enrollment
• Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function
• Current use of opioid pain medications (except for NSAIDs)
• Previous experience participating in dietary studies for IBS
• Current use of medications which are known to be affected by modest dietary changes
• Vitamin C use of >2000 mg/day
• Quercetin use of >500 mg/day