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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 bloating/distension, flatulence, abdominal pain and bowel habit changes. An alteration in the intestinal microbiome due to intestinal dysmotility, inflammation or other changes including pH changes in the intestine related to CFTR gene mutation may cause intestinal dysbiosis leading to a bacterial overgrowth in the proximal small intestine which may explain some of the findings of distension and bloating in CF.

Our small pilot study aims to investigate use of the only FDA-approved antibiotic, rifaximin for a GI syndrome- IBS, to treat bloating and global GI symptoms in CF patients with bloating and distension. Our goal is to recruit patients >12 years and age/sex matched into rifaximin and placebo arms with total of 100 recruited subjects recruited.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborators: Emory University; University of Minnesota; University of Texas Southwestern Medical Center
• Treatments: Rifaximin

Criteria

Inclusion Criteria:

1. Confirmed CF diagnosis who are enrolled in the CFF registry.

2. Patient ages ≥12 years and ≥ 30 kilograms (~66.15 lbs)

3. Ability to provide informed consent

Exclusion Criteria:

1. Patients who have previously been allergic to rifaximin or had a hypersensitivity to rifamycin

2. Patients with FEV1 < 40 will be excluded from the study given potential risks in patients with advanced lung disease

3. Patients who have taken any probiotics or new antibiotic for treatment of an acute pulmonary infection 4 weeks prior or during the study period

4. Patients with a recent pulmonary exacerbation defined as 4 weeks prior to screening will not be enrolled

5. Patients who are on probiotics will be asked to discontinue the use of probiotics 14 days prior to study enrolment as probiotics can alter the gut microbiome and cause bloating

6. Patients with newly initiated CFTR modulator treatments within one month prior to the study

7. Patients with new onset of DIOS (Distal Intestinal Obstruction Syndrome 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

9. Patients with bilirubin or alkaline phosphatase elevations >2x normal at baseline will be excluded as this may be related to CFTR modulator use