Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2014-07-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention Diet
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.
Personalized Dietary Advice
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.
Active control diet
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.
Personalized Dietary Advice
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.
Interventions
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Personalized Dietary Advice
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Cell Science Systems, Corp.
UNKNOWN
Yale University
OTHER
Responsible Party
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Principal Investigators
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Ather Ali, ND, MPH, MHS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Wajahat Mehal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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References
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Ali A, Weiss TR, McKee D, Scherban A, Khan S, Fields MR, Apollo D, Mehal WZ. Efficacy of individualised diets in patients with irritable bowel syndrome: a randomised controlled trial. BMJ Open Gastroenterol. 2017 Sep 20;4(1):e000164. doi: 10.1136/bmjgast-2017-000164. eCollection 2017.
Related Links
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BMJ Open Gastroenterology
Other Identifiers
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1404013784
Identifier Type: -
Identifier Source: org_study_id