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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01829932
Enrollment
30
Registered
2013-04-11
Start date
2013-04-30
Completion date
2014-12-31
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Diet

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.

Interventions

DIETARY_SUPPLEMENTFactor Altered Diet

Sponsors

Queen's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Area under the Curve of Hydrogen Gas on Lactulose Breath Test5 hours

Secondary

MeasureTime frame
Change in Area Under the Curve on Lactulose Breath Test from Baseline5 hours
Change in IBS Symptom Severity Score from Baseline3 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026