Rifaximin + Hydrogen Breath Test for IBS-D
Recruiting in Palo Alto (17 mi)
Overseen byWilliam Chey, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Michigan
Must not be taking: Antibiotics, Probiotics, P-glycoprotein inhibitors
Disqualifiers: Pregnancy, Diabetes, Celiac, others
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stop using antibiotics and probiotics before participating. Additionally, you cannot use P-glycoprotein inhibitors (a type of medication that affects how drugs are absorbed in the body) during the study.
What data supports the effectiveness of the drug Rifaximin for IBS-D?
Research shows that Rifaximin, a non-absorbable antibiotic, is effective in treating IBS-D by reducing symptoms like bloating and improving overall IBS symptoms. Studies have demonstrated its ability to eradicate small intestinal bacterial overgrowth (SIBO), which is linked to IBS, as shown by decreased hydrogen and methane levels in breath tests.
12345Is Rifaximin safe for humans?
Rifaximin is generally considered safe for humans as it is a minimally absorbed antibiotic, meaning it mostly stays in the gut and doesn't enter the bloodstream significantly. It has been used to treat various gut-related conditions, including travelers' diarrhea and irritable bowel syndrome with diarrhea (IBS-D), with a good safety profile.
13567What makes the drug Rifaximin unique for treating IBS-D?
Rifaximin is unique for treating IBS-D because it is a nonabsorbable antibiotic that works directly in the gut to reduce bacterial overgrowth, which is often linked to IBS-D symptoms. Unlike other treatments, it is specifically approved for IBS-D and can be guided by breath tests to predict patient response.
13568Eligibility Criteria
This trial is for individuals with Irritable Bowel Syndrome predominant diarrhea (IBS-D) who meet specific criteria of abdominal pain and diarrhea, have kept a symptom diary for at least 5 days without rescue meds, and fit the Rome IV Diagnostic Criteria. It's not open to those with certain other diseases like inflammatory bowel disease or diabetes, recent GI surgery patients, severe liver issues, pregnant or lactating women, anyone who has taken antibiotics recently or uses probiotics.Inclusion Criteria
IBS-D (Rome IV Diagnostic Criteria)
My abdominal pain and diarrhea are manageable.
I kept a health diary for 5 days without needing emergency meds.
Exclusion Criteria
I have inflammatory bowel disease, diabetes, systemic sclerosis, or celiac disease.
Pregnant women or planning on becoming pregnant while in the study, or lactating women while in the study
I am not taking any medications like Cyclosporine.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
Daily online surveys
Treatment
Participants receive a 14-day course of rifaximin and complete hydrogen breath tests
2 weeks
In-person visits for breath tests and biological sample collection
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of abdominal pain and stool consistency
4 weeks
Weekly assessments
Extended Follow-up
Continued monitoring of symptoms and quality of life measures
8 weeks
Assessments at weeks 4, 8, and 12
Participant Groups
The study tests if hydrogen breath testing can predict how well people with IBS-D respond to rifaximin treatment. Participants will take rifaximin and undergo glucose and lactulose hydrogen breath tests while providing biological samples and completing online surveys about their symptoms.
1Treatment groups
Experimental Treatment
Group I: Rifaximin and breath testsExperimental Treatment2 Interventions
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 is already approved in United States, Canada, European Union, India for the following indications:
🇺🇸 Approved in United States as Xifaxan for:
- Traveler's diarrhea
- Irritable bowel syndrome with diarrhea
- Hepatic encephalopathy
🇨🇦 Approved in Canada as Zaxine for:
- Traveler's diarrhea
- Irritable bowel syndrome with diarrhea
- Hepatic encephalopathy
🇪🇺 Approved in European Union as Xifaxan for:
- Traveler's diarrhea
- Irritable bowel syndrome with diarrhea
- Hepatic encephalopathy
🇮🇳 Approved in India as Ciboz and Xifapill for:
- Traveler's diarrhea
- Irritable bowel syndrome with diarrhea
- Hepatic encephalopathy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
Loading ...
Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
Commonwealth Diagnostics International, Inc.Collaborator
References
Preferential usage of rifaximin for the treatment of hydrogen-positive smallintestinal bacterial overgrowth. [2020]Small intestinal bacterial overgrowth (SIBO) is challenging to treat and diagnose and is associated with diagnosis of irritable bowel syndrome (IBS). Although no FDA-approved medications exist for treatment of SIBO, rifaximin has recently received approval to treat diarrhea-predominant IBS and patients with methane-positive SIBO breath tests. The aim of this study is to evaluate patient response to rifaximin for SIBO based on breath test results.
Rifaximin Treatment for Individual and Multiple Symptoms of Irritable Bowel Syndrome With Diarrhea: An Analysis Using New End Points. [2023]Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. The current aim was to evaluate rifaximin efficacy on individual and composite IBS-D symptoms using definitions not previously examined.
Lactulose Breath Testing as a Predictor of Response to Rifaximin in Patients With Irritable Bowel Syndrome With Diarrhea. [2023]The nonsystemic antibiotic rifaximin is indicated for irritable bowel syndrome with diarrhea (IBS-D) in adults; however, determinants of response remain unclear. The utility of lactulose breath testing (LBT) in predicting response to rifaximin was examined.
Rifaximin: The Revolutionary Antibiotic Approach for Irritable Bowel Syndrome. [2019]A large number of clinical studies using breath testing and a smaller number of studies using quantitative cultures of the upper small intestine established a link between irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO). A series of 12 studies both prospective and retrospective in design in a population of patients with SIBO without IBS showed that the non-absorbable antibiotic rifaximin can eradicate SIBO as proved through decrease of the exhaled hydrogen and methane in breath tests. The efficacy of rifaximin was superior over the comparator treatment in most of these studies. Based on these findings, short course rifaximin was tested in various concentrations in eight open-label trials in patients with IBS and proven SIBO by breath test. Similar efficacy of rifaximin was shown in SIBO eradication; this was accompanied by improvement of the global score for IBS symptoms. Finally, five double-blind randomized clinical trials were conducted in patients with IBS; four were placebo-controlled. The larger trials were TARGET 1 and TARGET 2 studies testing rifaximin at a regimen of 550 mg tid for 14 days. All trials showed a significant superiority of rifaximin over comparator for the improvement of global symptoms of IBS and bloating. Although the aforementioned results render rifaximin a revolutionary therapeutic approach for IBS, several concerns on induction of antimicrobial resistant flora remain.
[Clinical features of irritable bowel syndrome with small intestinal bacterial overgrowth and a preliminary study of effectiveness of Rifaximin]. [2018]To investigate the prevalence and clinical features of small intestinal bacterial overgrowth (SIBO) in diarrhea-predominant irritable bowel syndrome (IBS-D) patients detected by hydrogen and methane in lactulose breath test (LBT), and to study the effects of rifaximin in IBS-D patients.
Rifaximin for small intestinal bacterial overgrowth in patients without irritable bowel syndrome. [2021]Rifaximin is a minimally absorbed antibiotic with high luminal activity, used to treat various gastrointestinal diseases. Although rifaximin has been proposed as first line treatment for small intestinal bacterial overgrowth (SIBO), few data are available regarding its efficacy in non-IBS subjects. We aimed to assess the ability of rifaximin to normalize lactulose-H2 breath tests in non-IBS subjects with symptoms suggestive of SIBO.
Rifaximin: a nonabsorbed oral antibiotic. [2018]Rifaximin is a rifamycin analogue with a broad spectrum of activity similar to that of rifampin; however, because it is poorly absorbed in the gastrointestinal tract, the focus of its development has been on intestinal infections and diseases. This agent has proven to be as effective as ciprofloxacin in treating travelers' diarrhea due to Escherichia coli, although it is ineffective in treating infections due to Campylobacter jejuni. Other potential uses for rifaximin in gastroenterologic disorders include treatment of hepatic encephalopathy, intestinal gas and gas-related symptoms, diverticular disease, intestinal bacterial overgrowth, pouchitis, ulcerative colitis, and active Crohn's disease. This article highlights several studies demonstrating the efficacy of rifaximin in treating travelers' diarrhea as well as other gastrointestinal diseases and discusses the drug's pharmacokinetics, indications, contraindications, warnings, precautions, adverse reactions, and dosing.
A randomized double-blind placebo-controlled trial of rifaximin in patients with abdominal bloating and flatulence. [2022]To study the efficacy of rifaximin, a nonabsorbable antibiotic, in relieving chronic functional symptoms of bloating and flatulence.