Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis

Background: Chronic pancreatitis (CP) is a progressive inflammatory disorder causing irreversible pancreatic damage, eventually resulting in pancreatic exocrine insufficiency (PEI). This may lead to malabsorption, malnutrition, weight loss, and impaired quality of life. Pancreatic enzyme replacement therapy (PERT) is the standard treatment for PEI and is predominantly derived from porcine sources. However, religious, ethical, dietary, and supply-related concerns highlight the need for effective non-porcine alternatives. Microbial (fungal)-based pancreatic enzymes have shown promising safety and efficacy in preliminary studies, but evidence in CP remains limited. Objective: To compare the efficacy and safety of non-porcine microbial (fungal)-based pancreatin with standard porcine-based pancreatin in patients with PEI secondary to CP. Methods: This investigator-initiated, randomized, double-blind, single-center, non-inferiority trial will enroll 134 adults with CP-associated PEI (defined as having a fecal elastase \

Inclusion Criteria: * CP fulfilling the M-ANNHEIM criteria 11 with documented PEI (defined as fecal elastase \1.4 * Willingness to undergo a 2-week wash-out period without pancreatic enzyme therapy before enrolment. * Willing and able to provide written informed consent. Exclusion Criteria: * Major psychiatric illness impairing study participation. * Systemic illness affecting digestion or study outcomes. * Any condition deemed unsuitable for study participation by the investigator. * Concurrent acute exacerbation of the CP at the time of screening.