Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Wake Forest University Health Sciences
Collaborators:
Emory University University of Minnesota University of Texas Southwestern Medical Center