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

Q

Queen's University

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: Factor Altered Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01829932
DMED-1443-11

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups

High Factor Diet
Active Comparator group
Description:
Patients will be on a factor altered diet to see effects on their lactulose breath test and symptoms.
Treatment:
Dietary Supplement: Factor Altered Diet
Low Factor Diet
Active Comparator group
Description:
Patients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test.
Treatment:
Dietary Supplement: Factor Altered Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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