Status:
WITHDRAWN
Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Nationwide Children's Hospital
University of Minnesota
Conditions:
Cystic Fibrosis
Abdominal Pain
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
Gastrointestinal symptoms are commonly reported in as much as 65% of people with CF even independent of pancreatic enzyme replacement therapy (PERT) and the most frequent of these symptoms are bloatin...
Detailed Description
Gastrointestinal symptoms are commonly reported in persons with cystic fibrosis-both adults and pediatrics- and these symptoms cause distress, impact patients quality of life, and can lead to poor nut...
Eligibility Criteria
Inclusion
- Confirmed CF diagnosis who are enrolled in the CFF registry.
- Mild to severe symptom severity defined as abdominal Distention score ≥ 2 and/or bloating score ≥ 2 on a Likert Scale of 0-6)
- Patient age ≥12 years and ≥ 30 kilograms (\~66.15 lbs)
- Ability to provide informed consent or presence of legally authorized representative (LAR)
- Ability to take drug or placebo by mouth (Pill must be intact. May not be opened, crushed, or modified to aid in ingestion)
Exclusion
- 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
- 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 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.
- Subjects with a recent pulmonary exacerbation defined as 4 weeks prior to screening will not be enrolled
- 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
- Subjects with newly initiated cystic fibrosis transmembrane conductance regulator (CFTR) modulator treatments within one month prior to the study
- Subjects with new onset of distal intestinal obstruction syndrome (DIOS) or constipation
- 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
- 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
- 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.
- Known clostridium difficile colitis. Colonization with c. difficile is not exclusionary.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05408910
Start Date
July 1 2025
End Date
September 1 2025
Last Update
June 27 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.