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Irritable Bowel Syndrome and Food Sensitivity

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Dietary Advice
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, IBS, Diet, Food sensitivity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Diet

Active control diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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."
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."
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."
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 7, 2014
Last Updated
October 16, 2017
Sponsor
Yale University
Collaborators
Cell Science Systems, Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT02186743
Brief Title
Irritable Bowel Syndrome and Food Sensitivity
Official Title
Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Cell Science Systems, Corp.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, IBS, Diet, Food sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Active control diet
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Personalized Dietary Advice
Intervention Description
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 Measure Information:
Title
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
Description
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.
Time Frame
Baseline
Title
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
Description
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.
Time Frame
4 weeks
Title
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Irritable Bowel Syndrome Adequate Relief (IBS-AR)
Description
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."
Time Frame
Baseline
Title
Irritable Bowel Syndrome Adequate Relief (IBS-AR)
Description
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."
Time Frame
4 weeks
Title
Irritable Bowel Syndrome Adequate Relief (IBS-AR)
Description
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."
Time Frame
8 weeks
Title
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Description
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.
Time Frame
Baseline
Title
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Description
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.
Time Frame
4 weeks
Title
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Description
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.
Time Frame
8 weeks
Title
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
Description
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.
Time Frame
Baseline
Title
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
Description
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.
Time Frame
4 weeks
Title
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ather Ali, ND, MPH, MHS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wajahat Mehal, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29018540
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.
Results Reference
result
Links:
URL
http://bmjopengastro.bmj.com/content/4/1/e000164
Description
BMJ Open Gastroenterology

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Irritable Bowel Syndrome and Food Sensitivity

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