Clinical Trial

Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy

Study acronym: DCP-PCT-EPI
Not Yet Recruiting
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Summary
Pancreatic exocrine insufficiency (PEI) results from reduced pancreatic enzyme secretion, leading to malabsorption, malnutrition, and impaired quality of life. Although pancreatic enzyme replacement therapy (PERT) is the standard treatment, some patients remain symptomatic despite apparently adequate therapy. Possible causes include suboptimal dosing or concomitant conditions such as small intestinal bacterial overgrowth (SIBO). This study aims to determine the prevalence of SIBO in symptomatic PEI patients despite adequate PERT and to identify treatable causes of persistent symptoms using non-invasive diagnostic tests, with the goal of improving nutritional status and quality of life.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-04-08
notable Primary completion pushed: 2026-03-15 -> 2027-04-30 2026-04-08
minor Completion pushed: 2028-01-26 -> 2028-04-26 2026-04-08
Trial Details
NCT Number NCT07479238
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions SIBO, Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatic Surgey
Enrollment 100 participants
Start Date 2026-04-30
Primary Completion 2027-04-30 (estimated)
Study Completion 2028-04-26 (estimated)
Updated on ClinicalTrials.gov 2026-04-13