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Antibiotic
Rifaximin + Hydrogen Breath Test for IBS-D
Phase 4
Recruiting
Led By William Chey, M.D.
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diary compliance for at least 5 days and no rescue medications during baseline
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 1), up to 12 weeks
Awards & highlights
Study Summary
This trial is testing a new treatment for IBS-D, which includes online surveys, rifaximin, and hydrogen breath testing.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Rifaximin may cause side effects such as digestive disturbances (nausea, bloating), headaches, dizziness, increased risk of infection due to gut flora changes. The hydrogen breath test is generally safe but might cause some discomfort like bloating or cramping.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I kept a health diary for 5 days without needing emergency meds.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 1), up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 1), up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of treatment responders
Secondary outcome measures
Compare the predictive value of a pre-treatment glucose or lactulose hydrogen breath test
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 - Quality of Life Measure responder
+4 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
2005
Completed Phase 4
~3120
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,948 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
842 Patients Enrolled for Irritable Bowel Syndrome
Commonwealth Diagnostics International, Inc.UNKNOWN
William Chey, M.D.Principal Investigator - University of Michigan
University of Michigan C.S. Mott Children's Hospital, University of Michigan Health System, University of Michigan Hospital, Von Voigtlander Women's Hospital
Emory University School Of Medicine (Medical School)
University Of Mi Hosps (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have inflammatory bowel disease, diabetes, systemic sclerosis, or celiac disease.I am not taking any medications like Cyclosporine.I have severe liver problems.My abdominal pain and diarrhea are manageable.I have taken antibiotics in the last month.I have not had a stomach infection or diverticulitis in the last 3 months.I kept a health diary for 5 days without needing emergency meds.I am currently taking probiotics.I am currently being treated for cancer in my digestive system or blood.I have not had GI tract surgery in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Rifaximin and breath tests
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Irritable Bowel Syndrome Patient Testimony for trial: Trial Name: NCT03729271 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the typical indications for Rifaximin treatment?
"Rifaximin is extensively used for the remediation of recurrent clostridium difficile-associated infections. It's also employed therapeutically to address bacterial infections, irritable bowel syndrome (IBS) and other cases of diarrhea."
Answered by AI
What precautionary measures must be taken when administering Rifaximin to patients?
"Our experts at Power assessed Rifaximin's safety as a 3, signifying it is approved and has gone through several phases of clinical trials."
Answered by AI
What is the upper-limit of participants in this medical study?
"Affirmative. Clinicaltrials.gov specifies that this research, which was first made available on 1/9/2020 is actively recruiting patients to participate. At present, one medical centre needs 110 participants for the trial."
Answered by AI
Does the trial only consider applicants who are under 35 years of age?
"This medical trial is accessible to individuals aged 18 and below 80 years of age."
Answered by AI
Who is eligible to join this clinical research program?
"This research project is looking for 110 individuals with IBS aged 18 to 80. To be a suitable candidate, participants must fulfill the Rome IV Diagnostic Criteria for IBS-D and demonstrate at least 5 days of diary compliance without using any rescue medication during baseline periods as well as display appropriate levels of abdominal pain and diarrhea."
Answered by AI
Are there any vacancies in this experimental program?
"Affirmative. Clinicaltrials.gov data suggests that this research project, which first opened on September 1st 2020, is presently recruiting participants. A total of 110 subjects must be admitted from a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
West Virginia
How old are they?
65+
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
On the 63-year-old who has had irritable bowel syndrome for so long anything that can help relieve it that's what I'm looking for.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- University of Michigan: < 24 hours
Average response time
- < 2 Days
Typically responds via
Email
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