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Completed

NCT Number: NCT01829932

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Factor Altered Diet

Dietary Supplement

Primary outcomes

  1. Area under the Curve of Hydrogen Gas on Lactulose Breath Test

    Time frame: 5 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2013
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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