What side effects are associated with this type of intervention?

Common treatments for Cystic Fibrosis, especially antibiotics targeting bacterial overgrowth in the intestine like Rifaximin, often have side effects such as gastrointestinal disturbances, including bloating, flatulence, and abdominal pain. Rifaximin, specifically, is noted for its safety and efficacy in treating small intestinal bacterial overgrowth, with fewer systemic side effects due to its minimal absorption. Other antibiotics used in CF management, such as trimethoprim-sulfamethoxazole, may require higher doses and can lead to increased hepatic and renal clearance, potentially causing mild gastrointestinal symptoms and changes in bowel habits.

What prior FDA approvals exist?

The FDA has approved several treatments for Cystic Fibrosis, primarily focusing on managing lung infections and improving lung function. Notably, antibiotics like azithromycin are used for their anti-inflammatory properties and to manage chronic Pseudomonas aeruginosa infections. For gastrointestinal symptoms, which are common in CF, treatments like pancreatic enzyme replacement therapy (PERT) are standard. While Rifaximin is being studied for its potential to treat bloating and other GI symptoms in CF by targeting bacterial overgrowth, it is not yet FDA-approved specifically for CF. Other CF treatments include CFTR modulators like elexacaftor-tezacaftor-ivacaftor, which improve the function of the defective protein caused by CFTR gene mutations.

What other types of research exist?

Promising alternatives to Rifaximin for treating bacterial overgrowth in CF patients include: 1) Roxithromycin, which has shown efficacy in reducing mucosity and bacterial load in CF patients chronically colonized with Pseudomonas aeruginosa. 2) Rifampicin, which has demonstrated a significant reduction in mucosity and bacterial load in similar settings. Both antibiotics have shown potential benefits in modifying the mucoid character of Pseudomonas aeruginosa, a major virulence factor in CF.

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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

Awards & highlights

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks for reporting.

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.

0 / 9Eligibility criteria met

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 versus gluten-mediated inhibition in celiac disease.Targeting the Root Cause of Cystic Fibrosis.