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

Cystic Fibrosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 nutrition. One of the findings from our largest US study of patient-reported GI symptom outcomes in CF called GALAXY, which enrolled 402 adults and children with CF, was the finding of high rates of patient dissatisfaction with current GI treatments as well as commonly reported symptoms of bloating (48%), fullness (67%) with meals and abdominal distension (50%). This study aims to evaluate if this same-nonsystemically absorbed and noninvasive antibiotic can be used to treat similar commonly reported symptoms in people with CF. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05408910
Study type Interventional
Source Wake Forest University Health Sciences
Contact Baha Moshiree, MD
Phone 704-355-0244
Email bmoshire@wakehealth.edu
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date July 2024
Completion date September 2024
View Details
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