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Irritable Bowel Syndrome and Food Sensitivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02186743
First Posted: July 10, 2014
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cell Science Systems, Corp.
Information provided by (Responsible Party):
Yale University
  Purpose
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).

Condition Intervention
Irritable Bowel Syndrome Other: Personalized Dietary Advice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.


Secondary Outcome Measures:
  • 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."

  • 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."

  • 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."

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 58
Study Start Date: July 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186743


Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Cell Science Systems, Corp.
Investigators
Principal Investigator: Ather Ali, ND, MPH, MHS Yale University
Principal Investigator: Wajahat Mehal, MD, PhD Yale University
  More Information

Additional Information:
Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02186743     History of Changes
Other Study ID Numbers: 1404013784
First Submitted: July 7, 2014
First Posted: July 10, 2014
Last Update Posted: October 18, 2017
Last Verified: January 2016

Keywords provided by Yale University:
Irritable Bowel Syndrome
IBS
Diet
Food sensitivity

Additional relevant MeSH terms:
Syndrome
Hypersensitivity
Irritable Bowel Syndrome
Disease
Pathologic Processes
Immune System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases