Status:
COMPLETED
Irritable Bowel Syndrome and Food Sensitivity
Lead Sponsor:
Yale University
Collaborating Sponsors:
Cell Science Systems, Corp.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 random...
Detailed 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 counselin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT02186743
Start Date
July 1 2014
End Date
January 1 2016
Last Update
October 18 2017
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06519