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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Commonwealth Diagnostics International, Inc.
• Treatments: Lactulose; Rifamycins; Rifaximin

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