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

RecruitingPhase 3Ages 18 Years - 60 YearsAllAsian Institute of Gastroenterology, India
NCT07697352 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, dou

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. 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.
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What it tests

  • Dietary 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)
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Where

1 site
Asian Institute of Gastroenterology
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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