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 \<100 µg/g). After a two-week washout period, participants will be randomized 1:1 to receive either microbial-based or porcine-based pancreatin for 12 weeks. The primary outcome is the change from baseline in the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) score at 12 weeks. Secondary outcomes include nutritional status, anthropometric measures, gastrointestinal symptoms, pain scores, stool consistency, glycaemic parameters, laboratory markers, and quality of life.
Discussion: This study aims to evaluate whether microbial-based pancreatin is non-inferior to porcine-based therapy and may provide a culturally acceptable and sustainable alternative for managing CP-related PEI.
CP fulfilling the M-ANNHEIM criteria 11 with documented PEI (defined as fecal elastase <100 µg/g stool on the background of morphological changes of CP).
Pancreatic exocrine insufficiency questionnaire score (PEI-Q) >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.
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.
Parallel
Dietary Supplement: Pancreatic enzyme preparation from microbial source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC).
Dietary supplementDietary Supplement: Pancreatic enzyme preparation from microbial source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC).
Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U)
Other interventionStandard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U)
Change in Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) score
The PEI-Q is a validated questionnaire that captures several symptoms related to exocrine pancreatic insufficiency and the result is presented as a composite score.
Change in nutritional status: Subjective global assessment
Subjective global assessment (SGA) is a composite semi-quantitative tool that provides the degree of nutrition of an individual in three categories such as SGA A (Normal nutrition), SGA B (moderate malnutrition) and SGA C (Severe malnutrition).
Change in nutritional status: Body weight
Percent change in body weight (kg)
Change in nutritional status: Anthropometry
Mid-arm circumference (MAC) in cm.
Change in nutritional status: Anthropometry
Mid-upper arm muscle circumference (MAMC) in cm.
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Asian Institute of Gastroenterology, India
Lead sponsor
Aalborg University
Collaborator
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