Clinical trial NCT03729271: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea
Keywords: IBS
Irritable Bowel Syndrome
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Commonwealth Diagnostics International, Inc.
First posted: 2018-11-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of treatment responders
timeFrame: first 4 weeks after rifaximin treatment
Secondary outcomes:
measure: Severity of abdominal pain by numeric rating scale (0-10)
timeFrame: baseline (week 1), up to 12 weeks
measure: Stool consistency by Bristol Stool Form Scale (1-7)
timeFrame: baseline (week 1), up to 12 weeks
measure: Severity of bloating by numeric rating scale (0-10)
timeFrame: baseline (week 1), up to 12 weeks
measure: Severity of bowel urgency by rating scale (0-10)
timeFrame: baseline (week 1), up to 12 weeks
measure: Compare the predictive value of a pre-treatment glucose vs. lactulose hydrogen breath test for symptomatic response to rifaximin in IBS-D patients.
timeFrame: baseline (week 1), up to 12 weeks
measure: Irritable Bowel Syndrome - Quality of Life Measure responder
timeFrame: baseline (week 1), up to 12 weeks
measure: Compare the predictive value of a pre-treatment glucose or lactulose hydrogen breath test
timeFrame: first 4 weeks after rifaximin treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: William Chey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: