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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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High Factor Diet

Patients will be on a factor altered diet to see effects on their lactulose breath test and symptoms.

Group Type ACTIVE_COMPARATOR

Factor Altered Diet

Intervention Type DIETARY_SUPPLEMENT

Low Factor Diet

Patients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test.

Group Type ACTIVE_COMPARATOR

Factor Altered Diet

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Factor Altered Diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No