Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 2, 2022

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ClinConnect Summary

This clinical trial is studying the use of a medication called rifaximin to help reduce bloating and other gastrointestinal (GI) symptoms in children and adults with cystic fibrosis (CF). Many people with CF experience uncomfortable stomach issues, including bloating, abdominal pain, and changes in bowel habits, due to changes in their gut bacteria. This trial aims to recruit 100 participants aged 12 and older who have been diagnosed with CF and are experiencing moderate to severe bloating. Participants will be randomly assigned to receive either rifaximin or a placebo (a pill that looks the same but doesn’t contain the active medication) to see if rifaximin can improve their symptoms.

To be eligible for the study, participants must have a confirmed diagnosis of CF and be enrolled in the Cystic Fibrosis Foundation registry. They should also be able to swallow pills whole and have symptoms related to bloating that are significant enough to meet the study's criteria. Participants will need to provide informed consent, meaning they understand the study and agree to take part. It’s important to know that certain individuals, such as those with advanced lung disease or recent infections, will not be eligible to participate. The study has not started recruiting yet, but it offers a potential opportunity for those struggling with bloating due to cystic fibrosis to explore a new treatment approach.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Confirmed CF diagnosis who are enrolled in the CFF registry.
• • 2. Mild to severe symptom severity defined as abdominal Distention score ≥ 2 and/or bloating score ≥ 2 on a Likert Scale of 0-6)
• • 3. Patient age ≥12 years and ≥ 30 kilograms (\~66.15 lbs)
• • 4. Ability to provide informed consent or presence of legally authorized representative (LAR)
• • 5. Ability to take drug or placebo by mouth (Pill must be intact. May not be opened, crushed, or modified to aid in ingestion)
• Exclusion Criteria:
• • 1. Subjects who have previously been allergic to rifaximin or had a hypersensitivity to rifamycin or used rifaximin for any reason within three months (12 weeks) of the study start date
• • 2. 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
• • 3. Subjects who have received a new antibiotic for treatment of an acute pulmonary infection, or antibiotics for any other infection within 4 weeks prior to randomization or during the study period. Cyclic Antibiotics- Inhaled cyclic antibiotics are allowed at any timepoint. Oral or systemic cyclic antibiotics are exclusionary except for prophylactic antibiotics (e.g., azithromycin) which are allowed. New prophylactic antibiotics cannot be started within 4 weeks of randomization.
• • 4. Subjects with a recent pulmonary exacerbation defined as 4 weeks prior to screening will not be enrolled
• • 5. Subjects who are on probiotics will be asked to discontinue the use of probiotics 14 days prior to randomization as probiotics can alter the gut microbiome and cause bloating
• • 6. Subjects with newly initiated cystic fibrosis transmembrane conductance regulator (CFTR) modulator treatments within one month prior to the study
• • 7. Subjects with new onset of distal intestinal obstruction syndrome (DIOS) or constipation
• 8. 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
• • 9. Subjects with bilirubin or alkaline phosphatase elevations \> 2 times the upper limit of normal at screening will be excluded as this may be related to CFTR modulator use
• • 10. Women of childbearing potential who are pregnant, trying to become pregnant, breastfeeding, or not using an acceptable method of contraception as described in Section 6.2.
• • 11. Known clostridium difficile colitis. Colonization with c. difficile is not exclusionary.