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CompletedNCT01829932Updated Oct 14, 2015

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

An interventional study of Factor Altered Diet in Irritable Bowel Syndrome, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by Queen's University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • Diet
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In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 30 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Meet Rome III criteria for IBS
  • Willing to undergo dietary intervention

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementFactor Altered Diet
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What researchers measure

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

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Study locations

1 site
  • Hotel Dieu Hospital
    Kingston, Ontario K7L 5G2, Canada
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References and documents

Publications

  • 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. Erratum In: Gut. 2019 Jul;68(7):1342. doi: 10.1136/gutjnl-2015-311339corr1. PubMed 26976734 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01829932
Lead sponsor
Queen's University
Responsible party
Dr. Stephen Vanner (Professor of Medicine, Queen's University) — Principal investigator
First posted
Apr 11, 2013
Start date
Apr 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Oct 14, 2015

Study contacts

Stephen Vanner, MD, FRCPC
principal investigator · Queen's University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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