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

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea

Treatments: Device: Glucose and lactulose hydrogen breath testing; Drug: Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT03729271

HUM00142925

Details and patient eligibility

About

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.

Full 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 175 patients for the treatment phase of the study.

Enrollment: 148 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

148 participants in 1 patient group

Rifaximin and breath tests

Experimental group

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.

Treatment:

Drug: Rifaximin

Device: Glucose and lactulose hydrogen breath testing