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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03729271
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : December 5, 2022
Sponsor:
Collaborator:
Commonwealth Diagnostics International, Inc.
Information provided by (Responsible Party):
William Chey, University of Michigan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea Drug: Rifaximin Device: Glucose and lactulose hydrogen breath testing Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: 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
Official Title: The Role of Breath Testing in Enriching the Likelihood of Response to Rifaximin in Patients With Diarrhea IBS
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729271


Contacts
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Contact: Borko Nojkov, MD 734-936-9455 bnojkov@med.umich.edu
Contact: William Chey, M.D. 734-936-4775 wchey@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sam Chey, MPH    734-764-9226    schey@med.umich.edu   
Contact: Cathrin Ring, MS    734-936-2761    cathrinr@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Commonwealth Diagnostics International, Inc.
Investigators
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Principal Investigator: William Chey, M.D. University of Michigan
More Information
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Responsible Party: William Chey, Professor of Internal Medicine, Medical School and Professor of Nutritional Sciences, School of Public Health, University of Michigan
ClinicalTrials.gov Identifier: NCT03729271    
Other Study ID Numbers: HUM00142925
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022

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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
Keywords provided by William Chey, University of Michigan:
IBS
Irritable Bowel Syndrome
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Rifaximin
Lactulose
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents