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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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ClinicalTrials.gov Identifier: NCT01829932
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Stephen Vanner, Queen's University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Factor Altered Diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: High Factor Diet
Patients will be on a factor altered diet to see effects on their lactulose breath test and symptoms.
 Dietary Supplement: Factor Altered Diet
Active Comparator: Low Factor Diet
Patients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test.
 Dietary Supplement: Factor Altered Diet


Outcome Measures
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Primary Outcome Measures :
  1. Area under the Curve of Hydrogen Gas on Lactulose Breath Test [ Time Frame: 5 hours ]

Secondary Outcome Measures :
  1. Change in Area Under the Curve on Lactulose Breath Test from Baseline [ Time Frame: 5 hours ]
  2. Change in IBS Symptom Severity Score from Baseline [ Time Frame: 3 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT01829932


Locations
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Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: Stephen Vanner, MD, FRCPC Queen's University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Stephen Vanner, Professor of Medicine, Queen's University
ClinicalTrials.gov Identifier: NCT01829932    
Other Study ID Numbers: DMED-1443-11
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Dr. Stephen Vanner, Queen's University:
Diet
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases