Irritable Bowel Syndrome and Food Sensitivity

Yale University

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: Personalized Dietary Advice

Study type: Interventional

Funder types: Other

Identifiers

NCT02186743

1404013784

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Intervention Diet

Experimental group

Description:

Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.

Treatment:

Other: Personalized Dietary Advice

Active control diet

Active Comparator group

Description:

Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.

Treatment:

Other: Personalized Dietary Advice