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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03729271
• Other study ID #: HUM00142925
• Status: Recruiting
• Phase: Phase 4
• Start date: January 9, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: Borko Nojkov, MD
• Phone: 734-936-9455
• Email: bnojkov[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Drug:
• Rifaximin
Rifaximin will be given during weeks 2-4

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Commonwealth Diagnostics International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	first 4 weeks after rifaximin treatment
Secondary	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.	baseline (week 1), up to 12 weeks
Secondary	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.	baseline (week 1), up to 12 weeks
Secondary	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.	baseline (week 1), up to 12 weeks
Secondary	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.	baseline (week 1), up to 12 weeks
Secondary	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.	baseline (week 1), up to 12 weeks
Secondary	Irritable Bowel Syndrome - Quality of Life Measure responder	Defined as a decrease in score of 14 points from the baseline assessment. The score range is from 34 to 170, with decreasing in score indicating improvement in symptoms. Scores will be compared week 1 to those collected on weeks 4, 8, and 12.	baseline (week 1), up to 12 weeks
Secondary	Compare the predictive value of a pre-treatment glucose or lactulose hydrogen breath test	We will compare the proportion of patients meeting the primary response definition stratified by positive or negative glucose or lactulose breath test results	first 4 weeks after rifaximin treatment