Clinical trial

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

Name

HUM00142925

Description

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.

Trial arms

Trial start

2020-01-09

Estimated PCD

2025-01-01

Trial end

2025-01-01

Status

Recruiting

Phase

Early phase I

Treatment

Rifaximin

Rifaximin will be given during weeks 2-4

Arms:

Rifaximin and breath tests

Other names:

Xifaxan

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.

Arms:

Rifaximin and breath tests

Size

110

Primary endpoint

Number of treatment responders

first 4 weeks after rifaximin treatment

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}

Updated at

2024-01-25

1 organization

1 product

2 indications

Organization

University of Michigan

Product

Rifaximin

Indication

Irritable Bowel Syndrome

Indication

Irritable Bowel Syndrome with Diarrhea