The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 9, 2013
CompletedFirst Posted
Study publicly available on registry
April 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 14, 2015
October 1, 2015
1.7 years
April 9, 2013
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the Curve of Hydrogen Gas on Lactulose Breath Test
5 hours
Secondary Outcomes (2)
Change in Area Under the Curve on Lactulose Breath Test from Baseline
5 hours
Change in IBS Symptom Severity Score from Baseline
3 weeks
Study Arms (2)
High Factor Diet
ACTIVE COMPARATORPatients will be on a factor altered diet to see effects on their lactulose breath test and symptoms.
Low Factor Diet
ACTIVE COMPARATORPatients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test.
Interventions
Eligibility Criteria
You may qualify if:
- Meet Rome III criteria for IBS
- Willing to undergo dietary intervention
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
Related Publications (1)
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.
PMID: 26976734DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Vanner, MD, FRCPC
Queen's University
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
April 9, 2013
First Posted
April 11, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
October 14, 2015
Record last verified: 2015-10