Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea
Conditions
Keywords
IBS, Irritable Bowel Syndrome
Brief 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.
Detailed 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.
Interventions
DRUGRifaximin
Rifaximin will be given during weeks 2-4
DEVICEGlucose 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.
Sponsors
Commonwealth Diagnostics International, Inc.
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment responders | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool consistency by Bristol Stool Form Scale (1-7) | 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) | 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) | 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. |
| Severity of abdominal pain by numeric rating scale (0-10) | baseline (week 1), up to 12 weeks | A responder is defined as a patient with ≥30% decrease from baseline in mean weekly worst pain. |
| Irritable Bowel Syndrome - Quality of Life Measure responder | 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 | 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 |
| Compare the predictive value of a pre-treatment glucose vs. lactulose hydrogen breath test for symptomatic response to rifaximin in IBS-D patients. | 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. |
Countries
United States
Outcome results
None listed