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

Primary Purpose

Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Rifaximin

Glucose and lactulose hydrogen breath testing

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rifaximin and breath tests

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of treatment responders

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

Severity of abdominal pain by numeric rating scale (0-10)

A responder is defined as a patient with ≥30% decrease from baseline in mean weekly worst pain.

Stool consistency by Bristol Stool Form Scale (1-7)

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.

Severity of bloating by numeric rating scale (0-10)

A responder is defined as a patient with ≥ 30 % decrease from baseline in mean weekly worst bloating score.

Severity of bowel urgency by rating scale (0-10)

A responder is defined as a patient with ≥ 30 % decrease from baseline in mean weekly worst urgency score.

Compare the predictive value of a pre-treatment glucose vs. lactulose hydrogen breath test for symptomatic response to rifaximin in IBS-D patients.

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.

Irritable Bowel Syndrome - Quality of Life Measure responder

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.

Compare the predictive value of a pre-treatment glucose or lactulose hydrogen breath test

We will compare the proportion of patients meeting the primary response definition stratified by positive or negative glucose or lactulose breath test results

Full Information

NCT ID

NCT03729271

First Posted

October 10, 2018

Last Updated

December 2, 2022

Sponsor

University of Michigan

Collaborators

Commonwealth Diagnostics International, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03729271

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 9, 2020 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

Commonwealth Diagnostics International, Inc.

4. Oversight

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.

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea

Keywords

IBS, Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study 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.

Allocation

N/A

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rifaximin and breath tests

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Rifaximin

Other Intervention Name(s)

Xifaxan

Intervention Description

Rifaximin will be given during weeks 2-4

Intervention Type

Device

Intervention Name(s)

Glucose and lactulose hydrogen breath testing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of treatment responders

Description

Time Frame

first 4 weeks after rifaximin treatment

Secondary Outcome Measure Information:

Title

Severity of abdominal pain by numeric rating scale (0-10)

Description

A responder is defined as a patient with ≥30% decrease from baseline in mean weekly worst pain.

Time Frame