Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea
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|ClinicalTrials.gov Identifier: NCT03729271|
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : December 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea||Drug: Rifaximin Device: Glucose and lactulose hydrogen breath testing||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||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.|
|Official Title:||The Role of Breath Testing in Enriching the Likelihood of Response to Rifaximin in Patients With Diarrhea IBS|
|Actual Study Start Date :||January 9, 2020|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
Experimental: Rifaximin and breath tests
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.
Rifaximin will be given during weeks 2-4
Other Name: Xifaxan
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.
- Number of treatment responders [ Time Frame: first 4 weeks after rifaximin treatment ]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
- Severity of abdominal pain by numeric rating scale (0-10) [ Time Frame: baseline (week 1), up to 12 weeks ]A responder is defined as a patient with ≥30% decrease from baseline in mean weekly worst pain.
- Stool consistency by Bristol Stool Form Scale (1-7) [ Time Frame: baseline (week 1), up to 12 weeks ]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.
- Severity of bloating by numeric rating scale (0-10) [ Time Frame: baseline (week 1), up to 12 weeks ]A responder is defined as a patient with ≥ 30 % decrease from baseline in mean weekly worst bloating score.
- Severity of bowel urgency by rating scale (0-10) [ Time Frame: baseline (week 1), up to 12 weeks ]A responder is defined as a patient with ≥ 30 % decrease from baseline in mean weekly worst urgency score.
- Compare the predictive value of a pre-treatment glucose vs. lactulose hydrogen breath test for symptomatic response to rifaximin in IBS-D patients. [ Time Frame: baseline (week 1), up to 12 weeks ]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.
- Irritable Bowel Syndrome - Quality of Life Measure responder [ Time Frame: baseline (week 1), up to 12 weeks ]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.
- Compare the predictive value of a pre-treatment glucose or lactulose hydrogen breath test [ Time Frame: first 4 weeks after rifaximin treatment ]We will compare the proportion of patients meeting the primary response definition stratified by positive or negative glucose or lactulose breath test results
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729271
|Contact: Borko Nojkov, MDfirstname.lastname@example.org|
|Contact: William Chey, M.D.||email@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Cathrin Ring, M.S. 734-936-2761 firstname.lastname@example.org|
|Principal Investigator:||William Chey, M.D.||University of Michigan|