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Antibiotic
Rifaximin for Bloating in Cystic Fibrosis
Phase 2 & 3
Waitlist Available
Led By Baha Moshiree, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed CF diagnosis who are enrolled in the CFF registry
Patient age ≥12 years and ≥ 30 kilograms (~66.15 lbs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
Study Summary
This trial is investigating whether the antibiotic rifaximin can help with gastrointestinal symptoms in people with cystic fibrosis.
Who is the study for?
This trial is for children and adults over 12 years old, weighing more than 30 kilograms, with confirmed cystic fibrosis experiencing bloating. Participants must not have severe lung impairment or recent antibiotic use and should be able to swallow pills whole. Pregnant women or those trying to conceive are excluded.Check my eligibility
What is being tested?
The study tests Rifaximin, an FDA-approved antibiotic for IBS-related symptoms, against a placebo in treating gastrointestinal issues like bloating in cystic fibrosis patients. The goal is to enroll 100 participants into two groups: one receiving Rifaximin and the other a placebo.See study design
What are the potential side effects?
Potential side effects of Rifaximin may include digestive disturbances such as nausea, gas, altered bowel movements; headache; dizziness; fatigue; and allergic reactions in those sensitive to rifamycin antibiotics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am diagnosed with cystic fibrosis and registered with the CFF.
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I am 12 years or older and weigh at least 66 pounds.
Select...
I experience moderate to severe abdominal swelling or bloating.
Select...
I can swallow pills without altering them.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rifaximin Treatment Group Improvement of Symptoms
Secondary outcome measures
Improved ePROS scores
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Participants in this arm will receive Rifaximin 550 mg three times daily for 14 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive placebo three times daily for 14 days.
Find a Location
Who is running the clinical trial?
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,403 Total Patients Enrolled
4 Trials studying Cystic Fibrosis
107 Patients Enrolled for Cystic Fibrosis
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,083 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
20 Patients Enrolled for Cystic Fibrosis
Emory UniversityOTHER
1,636 Previous Clinical Trials
2,560,473 Total Patients Enrolled
20 Trials studying Cystic Fibrosis
1,846 Patients Enrolled for Cystic Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been allergic to rifaximin or had a reaction to rifamycin, nor have I used rifaximin in the last 3 months.My lung function is not severely reduced.I have advanced liver disease or my liver tests are more than three times the normal limit.I am diagnosed with cystic fibrosis and registered with the CFF.I have not had a lung flare-up in the last 4 weeks.I am not pregnant, trying to get pregnant, breastfeeding, or I am using approved birth control.I will stop taking probiotics 14 days before the study starts.I haven't taken new antibiotics for an infection in the last 4 weeks, except for inhaled ones or ongoing prophylactics.My liver tests for bilirubin and alkaline phosphatase are normal.I have been diagnosed with clostridium difficile colitis.I have recently developed a blockage in my intestines or constipation.I am 12 years or older and weigh at least 66 pounds.I started a new CFTR modulator treatment for cystic fibrosis less than a month ago.I experience moderate to severe abdominal swelling or bloating.I can swallow pills without altering them.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would it be possible to join this clinical trial?
"Unfortunately, this particular clinical trial is no longer recruiting patients. Although the original posting was on December 1st, 2022, the most recent edit was on September 28th, 2022. However, there are 457 other trials that are still looking for participants."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’m in need of SIBO TREATMENT. Just diagnosed for the first time.
PatientReceived no prior treatments
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