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The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Factor Altered Diet

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Diet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meet Rome III criteria for IBS
Willing to undergo dietary intervention

Exclusion Criteria:

History of Gastric, Small Bowel or Colonic Surgery
History of Inflammatory Bowel Disease
Celiac Disease
Unable to come off following medications: antibiotics, laxatives, narcotics, sedatives
On a pre specified diet
Pregnant

Sites / Locations

Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

High Factor Diet

Low Factor Diet

Arm Description

Patients will be on a factor altered diet to see effects on their lactulose breath test and symptoms.

Patients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test.

Outcomes

Primary Outcome Measures

Area under the Curve of Hydrogen Gas on Lactulose Breath Test

Secondary Outcome Measures

Change in Area Under the Curve on Lactulose Breath Test from Baseline

Change in IBS Symptom Severity Score from Baseline

Full Information

NCT ID

NCT01829932

First Posted

April 9, 2013

Last Updated

October 13, 2015

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT01829932

Brief Title

The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study

Official Title

The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to influence the bacteria gut interaction. Our aim is to determine if components of the diet affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure whether after being on a diet high or low on certain factors there is a change in the timing and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS symptom severity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Factor Diet

Arm Type

Active Comparator

Arm Description

Patients will be on a factor altered diet to see effects on their lactulose breath test and symptoms.

Arm Title

Low Factor Diet

Arm Type

Active Comparator

Arm Description

Patients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test.

Intervention Type

Dietary Supplement

Intervention Name(s)

Factor Altered Diet

Primary Outcome Measure Information:

Title

Area under the Curve of Hydrogen Gas on Lactulose Breath Test

Time Frame

5 hours

Secondary Outcome Measure Information:

Title

Change in Area Under the Curve on Lactulose Breath Test from Baseline

Time Frame

5 hours

Title

Change in IBS Symptom Severity Score from Baseline

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet Rome III criteria for IBS Willing to undergo dietary intervention Exclusion Criteria: History of Gastric, Small Bowel or Colonic Surgery History of Inflammatory Bowel Disease Celiac Disease Unable to come off following medications: antibiotics, laxatives, narcotics, sedatives On a pre specified diet Pregnant

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Vanner, MD, FRCPC

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hotel Dieu Hospital

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5G2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

26976734

Citation

McIntosh K, Reed DE, Schneider T, Dang F, Keshteli AH, De Palma G, Madsen K, Bercik P, Vanner S. FODMAPs alter symptoms and the metabolome of patients with IBS: a randomised controlled trial. Gut. 2017 Jul;66(7):1241-1251. doi: 10.1136/gutjnl-2015-311339. Epub 2016 Mar 14. Erratum In: Gut. 2019 Jul;68(7):1342.

Results Reference

derived

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The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study

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