Irritable Bowel Syndrome and Food Sensitivity

NCT02186743 | Completed DMC

• 1 other identifier: 1404013784
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; IBS; Diet; Food sensitivity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Irritable Bowel Syndrome Adequate Relief (IBS-AR)

  Baseline

• Irritable Bowel Syndrome Adequate Relief (IBS-AR)

  4 weeks

• Irritable Bowel Syndrome Adequate Relief (IBS-AR)

  8 weeks

• Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)

  Baseline

• Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)

  4 weeks

Study Arms (2)

Intervention Diet

EXPERIMENTAL

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

Active control diet

ACTIVE COMPARATOR

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

Interventions

Personalized Dietary Advice OTHER

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 control diet; Intervention Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Cell Science Systems, Corp.: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• 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.

  PMID: 29018540 RESULT

Related Links

• BMJ Open Gastroenterology

MeSH Terms

Conditions

Irritable Bowel Syndrome; Food Intolerance

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ather Ali, ND, MPH, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

• Wajahat Mehal, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 18, 2017

Record last verified: 2016-01

Locations

US (1)