Irritable Bowel Syndrome and Food Sensitivity

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Active control diet	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.
Intervention Diet	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.

Primary Outcome Measures

Name	Time	Method
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)	8 weeks	The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.

Secondary Outcome Measures

Name	Time	Method
Irritable Bowel Syndrome Adequate Relief (IBS-AR)	8 weeks	The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)	8 weeks	The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)	8 weeks	The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.

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