Irritable Bowel Syndrome and Food Sensitivity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Personalized Dietary Advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Diet<br>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. | Other: Personalized Dietary Advice<br>* 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.<br>|
| Active Comparator: Active control diet<br>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. | Other: Personalized Dietary Advice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS) | 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. | Baseline | 
| Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS) | 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. | 4 weeks | 
| Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS) | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable Bowel Syndrome Adequate Relief (IBS-AR) | 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. | Baseline | 
| Irritable Bowel Syndrome Adequate Relief (IBS-AR) | 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. | 4 weeks | 
| Irritable Bowel Syndrome Adequate Relief (IBS-AR) | 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. | 8 weeks | 
| Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) | 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. | Baseline | 
| Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) | 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. | 4 weeks | 
| Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) | 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. | 8 weeks | 
| Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL) | 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. | Baseline | 
| Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL) | 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. | 4 weeks | 
| Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL) | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, IBS, Diet, Food sensitivity