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

University of Michigan148 enrolled

Overview

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.

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 175 patients for the treatment phase of the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea

Interventions

RifaximinDRUG

Rifaximin will be given during weeks 2-4

Glucose and lactulose hydrogen breath testingDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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

Time frame: first 4 weeks after rifaximin treatment

Secondary Outcomes

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.

Time frame: baseline (week 1), up to 12 weeks

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.

Time frame: baseline (week 1), up to 12 weeks

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.

Time frame: baseline (week 1), up to 12 weeks

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.

Time frame: 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.

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.

Data from ClinicalTrials.gov

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