Microbial pancreatic enzyme therapy versus porcine enzyme in chronic pancreatitis with exocrine pancreatic insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults with chronic pancreatitis who have exocrine pancreatic insufficiency, researchers compare a microbial-fungal pancreatic enzyme preparation to the conventional porcine-derived product. The trial is randomized, double-blind, and non-inferiority in design, enrolling about 134 participants at a single center. Participants will undergo a 2-week wash-out period before starting treatment and will receive structured enzyme therapy to assess digestion, nutrition, and safety. Outcomes focus on efficacy in digestion and overall tolerability alongside safety signals. The study aims to determine if the microbial product can provide comparable benefit to the porcine standard, addressing non-porcine alternatives for enzyme replacement therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Asian Institute of Gastroenterology
  Hyderabad, Telangana, India Recruiting

Study contacts

• Principal investigator: Rupjyoti Talukdar, MD — Asian Institute of Gastroenterology, India
• Study coordinator: Rupjyoti Talukdar, MD
• Email: rup_talukdar@yahoo.com
• Phone: +917032804231

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.