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

NCT07697352 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: NP-PERT 1
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency (EPI)

Keywords

chronic pancreatitis; exocrine pancreatic insufficiency; Pancreatic enzyme replacement therapy; porcine pancreatic enzyme; microbial (fungal) pancreatic enzyme

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (28)

• Change in nutritional status: Subjective global assessment

  3 months

• Change in nutritional status: Body weight

  3 months

• Change in nutritional status: Anthropometry

  3 months

• Change in nutritional status: Anthropometry

  3 months

• Change in nutritional status: Anthropomentry

  3 months

Study Arms (2)

Non-porcine microbial (fungal) based pancreatic enzyme preparation

EXPERIMENTAL

The non-porcine microbial enzyme preparation will contain amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC)

Dietary Supplement: Dietary Supplement: Pancreatic enzyme preparation from microbial (fungal) source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC).

Standard of care porcine pancreatic enzyme

ACTIVE COMPARATOR

The standard of care porcine-based enzyme preparation will contain amylase (8000 U), lipase (25000 U), and protease (1000 U)

Other: Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U)

Interventions

Dietary Supplement: Pancreatic enzyme preparation from microbial (fungal) source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC). DIETARY_SUPPLEMENT

Dietary Supplement: Pancreatic enzyme preparation from microbial (fungal) source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC).

Non-porcine microbial (fungal) based pancreatic enzyme preparation

Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U) OTHER

Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U)

Standard of care porcine pancreatic enzyme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Willingness to undergo a 2-week wash-out period without pancreatic enzyme therapy before enrolment.
• Willing and able to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: collaborator
• Asian Institute of Gastroenterology, India: lead

Related Publications (12)

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  PMID: 28332032 BACKGROUND

• Salhi A, Amara S, Mansuelle P, Puppo R, Lebrun R, Gontero B, Aloulou A, Carriere F. Characterization of all the lipolytic activities in pancreatin and comparison with porcine and human pancreatic juices. Biochimie. 2020 Feb;169:106-120. doi: 10.1016/j.biochi.2019.07.004. Epub 2019 Jul 6.

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• Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials. JAMA. 2025 Aug 5;334(5):435-443. doi: 10.1001/jama.2025.4486.

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  PMID: 27941156 BACKGROUND

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MeSH Terms

Conditions

Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency

Interventions

Lipase; Peptide Hydrolases

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Rupjyoti Talukdar, MD

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupjyoti Talukdar, MD

CONTACT

+917032804231; rup_talukdar@yahoo.com

Abdul Rasheed, PharmD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pancreatology

Model Details: Multi-center, randomized, double-blind, parallel-group (1:1), placebo-controlled, non-inferior trial

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07