Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea

January 24, 2024 updated by: William Chey, University of Michigan

The Role of Breath Testing in Enriching the Likelihood of Response to Rifaximin in Patients With Diarrhea IBS

The purpose of this study is to learn more about how to improve treatment of patients with diarrhea predominant Irritable Bowel Syndrome (IBS-D) symptoms.Included patients will be requested to answer online surveys and will undergo treatment with rifaximin. Hydrogen breath testing and biologic samples collection will also be completed during the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • IBS-D (Rome IV Diagnostic Criteria)
  • Diary compliance for at least 5 days and no rescue medications during baseline
  • Appropriate levels of abdominal pain and diarrhea

Exclusion Criteria:

  • Pregnant women or planning on becoming pregnant while in the study, or lactating women while in the study
  • Inflammatory bowel disease, diabetes mellitus, systemic sclerosis, or celiac disease
  • Active gastrointestinal or hematological malignancy which requires ongoing treatment
  • Surgery to the GI tract in the past 3 months
  • Gastrointestinal infection or diverticulitis in the past 3 months
  • Severe hepatic impairment
  • Any use of antibiotics in the past month
  • Current use of probiotics
  • Any history of allergies to rifaximin or its derivatives
  • Any comitant use of P-glycoprotein inhibitors (for example. Cyclosporine)
  • Known allergies to glucose or lactulose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rifaximin and breath tests
Rifaximin 550mg three times a day for 14 days. Breath tests (glucose and lactulose) will be completed prior to Rifaximin treatment and at week 13 of the study.
Drug: Rifaximin
Rifaximin will be given during weeks 2-4
Other Names:
  • Xifaxan
Device: Glucose and lactulose hydrogen breath testing
Subjects will undergo glucose and lactulose hydrogen breath tests for Small Intestinal Bacterial Overgrowth (SIBO) on consecutive days using a commercially available home base kits (Glucose Hydrogen Breath Test Collection Kit and Lactulose Hydrogen Breath Test Collection Kit for SIBO from Commonwealth Diagnostic International) prior to Rifaximin treatment and at week 13 of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment responders
Time Frame: first 4 weeks after rifaximin treatment
A responder is defined as a patient simultaneously meeting weekly response criteria for abdominal pain (≥30% decrease from baseline in mean weekly pain score) and stool consistency (≥50% decrease from baseline in number of days/week with Bristol Stool Scale type 6 or 7 stool) during ≥2 of the 4 weeks after treatment
first 4 weeks after rifaximin treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of abdominal pain by numeric rating scale (0-10)
Time Frame: baseline (week 1), up to 12 weeks
A responder is defined as a patient with ≥30% decrease from baseline in mean weekly worst pain.
baseline (week 1), up to 12 weeks
Stool consistency by Bristol Stool Form Scale (1-7)
Time Frame: baseline (week 1), up to 12 weeks
A responder is defined as a patient with ≥ 50% decrease from baseline in number of days/weeks with Bristol stool scale type 6 or 7 stool.
baseline (week 1), up to 12 weeks
Severity of bloating by numeric rating scale (0-10)
Time Frame: baseline (week 1), up to 12 weeks
A responder is defined as a patient with ≥ 30 % decrease from baseline in mean weekly worst bloating score.
baseline (week 1), up to 12 weeks
Severity of bowel urgency by rating scale (0-10)
Time Frame: baseline (week 1), up to 12 weeks
A responder is defined as a patient with ≥ 30 % decrease from baseline in mean weekly worst urgency score.
baseline (week 1), up to 12 weeks
Compare the predictive value of a pre-treatment glucose vs. lactulose hydrogen breath test for symptomatic response to rifaximin in IBS-D patients.
Time Frame: baseline (week 1), up to 12 weeks
Irritable Bowel Syndrome- Severity Scoring system (IBS-SSS) responder decrease in score of >75 points compared to baseline. The scoring range is from 0% to 500% with decreasing points indicating improvements in symptoms. Scores will be compared week 1 to those collected on weeks 4, 8, and 12.
baseline (week 1), up to 12 weeks
Irritable Bowel Syndrome - Quality of Life Measure responder
Time Frame: baseline (week 1), up to 12 weeks
Defined as a decrease in score of 14 points from the baseline assessment. The score range is from 34 to 170, with decreasing in score indicating improvement in symptoms. Scores will be compared week 1 to those collected on weeks 4, 8, and 12.
baseline (week 1), up to 12 weeks
Compare the predictive value of a pre-treatment glucose or lactulose hydrogen breath test
Time Frame: first 4 weeks after rifaximin treatment
We will compare the proportion of patients meeting the primary response definition stratified by positive or negative glucose or lactulose breath test results
first 4 weeks after rifaximin treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Commonwealth Diagnostics International, Inc.

Investigators

  • Principal Investigator: William Chey, M.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00142925

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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