Phase 2 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are aged 12 or older (if in the US) or 18 or older (if in the EU)
• You have a confirmed and documented diagnosis of cystic fibrosis (CF)
• You have been diagnosed with severe exocrine pancreatic insufficiency (EPI), meaning your pancreas is not releasing enough digestive enzymes — confirmed by a specific stool test result at the start of the study
• Your EPI is currently under control, and you have been taking a stable dose of pancreatic enzyme replacement therapy (PERT) for at least 90 days before the study begins
• You have an adequate body weight for your height (BMI): at or above the 25th percentile for ages 12–17, or at or above 18.5 kg/m² for adults 18 and older

Who may not be able to join:

• You have a history of a serious scarring condition of the colon (fibrosing colonopathy) or repeated serious bowel blockages within the last 6 months
• You have had a lung or liver transplant, are on a waiting list for an organ transplant, or have had a significant portion of your bowel surgically removed in the last 6 months (confirm with trial site if you have had any bowel surgery)
• You have a known allergy or serious reaction to any ingredient in the study drug, a medicine called Creon, or a blue food dye used in the study (FD&C Blue #2)
• You have a long-term diarrhoea condition not related to your pancreas, are currently being treated for a bacterial overgrowth in your small intestine, need a feeding tube during the study, have had a specific gut infection called Clostridioides difficile within the last 6 months, or have severe constipation (fewer than one bowel movement per week)

Important: Always verify eligibility with the trial site directly before applying.