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

NCT05408910 Phase 2/Phase 3 WITHDRAWN

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.

Details

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2/Phase 3
Status	WITHDRAWN
Start date	2025-07
Completion	2025-09

Conditions

• Cystic Fibrosis
• Abdominal Pain
• Small Bowel Disease

Interventions

• Rifaximin 550 MG Oral Tablet [XIFAXAN]
• Placebo

Primary outcomes

• Rifaximin Treatment Group Improvement of Symptoms — Two weeks
  The primary aim and outcome of our study is to show a significant improvement in individual symptoms of abdominal bloating and/or distension, in PwCF (People with Cystic Fibrosis) treated with rifaximin as compared to placebo