Irritable Bowel Syndrome and Food Sensitivity

October 16, 2017 updated by: Yale University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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 Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Cell Science Systems, Corp.

Investigators

  • Principal Investigator: Ather Ali, ND, MPH, MHS, Yale University
  • Principal Investigator: Wajahat Mehal, MD, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404013784

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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