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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829932
• Other study ID #: DMED-1443-11
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: October 13, 2015
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Factor Altered Diet

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Curve of Hydrogen Gas on Lactulose Breath Test		5 hours	No
Secondary	Change in Area Under the Curve on Lactulose Breath Test from Baseline		5 hours	No
Secondary	Change in IBS Symptom Severity Score from Baseline		3 weeks	No