Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Irritable Bowel Syndrome
- Irritable Bowel Syndrome With Diarrhea
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Masking Description: The study drug will be open label. However, the order of the breath tests that are performed (glucose and lactulose) will be blinded to the participant and the person performing the breath sample, and the results of the breath test.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
The study aims to determine whether hydrogen breath testing can be used to identify patients with IBS-D who are more likely to respond to rifaximin. Participating patients will complete a one week screening period when brief daily survey will be answered. Eligible patients will proceed with the trea...
The study aims to determine whether hydrogen breath testing can be used to identify patients with IBS-D who are more likely to respond to rifaximin. Participating patients will complete a one week screening period when brief daily survey will be answered. Eligible patients will proceed with the treatment phase of the study, when patients will receive a 14 day course of rifaximin. All included patients will complete glucose and lactulose hydrogen breath tests before and after rifaximin treatment. Biological samples (e.g. blood, stool) will be collected at pre-determined time points and patients will answer daily brief survey for the duration of the study. It is anticipated that 210 patients will be screened to reach a goal of enrolling 110 patients for the treatment phase of the study.
Tracking Information
- NCT #
- NCT03729271
- Collaborators
- Commonwealth Diagnostics International, Inc.
- Investigators
- Principal Investigator: William Chey, M.D. University of Michigan
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