Clinical trial NCT02186743: Irritable Bowel Syndrome and Food Sensitivity
Official title: Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
IBS
Diet
Food sensitivity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Cell Science Systems, Corp.
First posted: 2014-07-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 randomized controlled trial in adults with irritable bowel syndrome (IBS).

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 counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments will occur at baseline, 4-weeks, and 8-weeks post-baseline.

Eligibility criteria: 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

Primary outcomes:
measure: Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
timeFrame: Baseline
measure: Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
timeFrame: 4 weeks
measure: Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Irritable Bowel Syndrome Adequate Relief (IBS-AR)
timeFrame: Baseline
measure: Irritable Bowel Syndrome Adequate Relief (IBS-AR)
timeFrame: 4 weeks
measure: Irritable Bowel Syndrome Adequate Relief (IBS-AR)
timeFrame: 8 weeks
measure: Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
timeFrame: Baseline
measure: Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
timeFrame: 4 weeks
measure: Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
timeFrame: 8 weeks
measure: Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
timeFrame: Baseline
measure: Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
timeFrame: 4 weeks
measure: Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Ather Ali, ND, MPH, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Wajahat Mehal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.