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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)
Must not have
Subjects with FEV1 < 40 (as measured within the last 12 months) will be excluded from the study given potential risks in subjects with advanced lung disease
Subjects with advanced liver disease defined by portal hypertension and/or child Pugh B or C cirrhosis or those with elevated liver enzymes-both AST/ALT > 3 times the upper limit of normal at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Summary
This trial is testing rifaximin, an antibiotic, to help people with cystic fibrosis who have gut symptoms like bloating. The antibiotic works by balancing gut bacteria to reduce discomfort. Rifaximin has been used to treat travelers' diarrhea and other conditions, and it has shown effectiveness in reducing symptoms of irritable bowel syndrome (IBS).
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.
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.
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.
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I experience moderate to severe abdominal swelling or bloating.
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I can swallow pills without altering them.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lung function is not severely reduced.
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I have advanced liver disease or my liver tests are more than three times the normal limit.
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I am not pregnant, trying to get pregnant, breastfeeding, or I am using approved birth control.
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My liver tests for bilirubin and alkaline phosphatase are normal.
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I have recently developed a blockage in my intestines or constipation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rifaximin Treatment Group Improvement of Symptoms
Secondary study objectives
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Cystic Fibrosis (CF) include CFTR modulators and antibiotics. CFTR modulators, such as elexacaftor-tezacaftor-ivacaftor, work by correcting the function of the defective CFTR protein, which is the root cause of CF.
This leads to improved pulmonary and gastrointestinal function. Antibiotics like rifaximin target bacterial overgrowth in the intestine, addressing symptoms like bloating and abdominal pain that are common in CF patients.
These treatments are essential as they help manage both the primary defect and secondary complications, thereby improving the overall quality of life for CF patients.
Cystic fibrosis transmembrane conductance regulator (CFTR) and autophagy: hereditary defects in cystic fibrosis <i>versus</i> gluten-mediated inhibition in celiac disease.Targeting the Root Cause of Cystic Fibrosis.
Cystic fibrosis transmembrane conductance regulator (CFTR) and autophagy: hereditary defects in cystic fibrosis <i>versus</i> gluten-mediated inhibition in celiac disease.Targeting the Root Cause of Cystic Fibrosis.
Find a Location
Who is running the clinical trial?
Nationwide Children's HospitalOTHER
348 Previous Clinical Trials
5,227,682 Total Patients Enrolled
4 Trials studying Cystic Fibrosis
107 Patients Enrolled for Cystic Fibrosis
Wake Forest University Health SciencesLead Sponsor
1,359 Previous Clinical Trials
1,039,699 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
20 Patients Enrolled for Cystic Fibrosis
Emory UniversityOTHER
1,690 Previous Clinical Trials
2,603,293 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.
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