Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis

NCT07441824 · tracked via the Priya Life Science India tracker

Sponsor

Asian Institute of Gastroenterology, India

Phase

Phase 3

Started

2026-04-10

Last updated

2026-05-05

Condition(s) studied

Acute Necrotizing PancreatitisPancreatic Exocrine Insufficiency

Investigational drug(s) / intervention(s)

Pancreatic enzyme capsulesPlacebo

Pancreatic enzyme capsules: Enteric coated pancreatic enzyme

Placebo: Similar appearing glucose capsules

Study summary

In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, the investigators propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). The investigators will include patients of 18-60yrs age and both genders with \>50% pancreatic parenchymal necrosis and at least 5% loss of body weight.

The primary outcome measure is percent change in body weight at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: * Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria * Index episode of acute pancreatitis with more than 50% pancreatic parenchymal necrosis and at least 5% loss of pre pancreatitis body weight at the time of screening * Within 6 weeks of onset of disease * Able to take food orally * Age 18-60 years * Both genders Exclusion Criteria: * Underlying chronic pancreatitis * Recurrent acute pancreatitis * Pancreatic cancer * Patients being discharged with NJ tubes * Pregnancy and lactation * Inability to give informed consent.

Primary outcome measure(s)

Percent change in body weight — 3 months
Body weight (in kg) will be measured at baseline and again at 3 months follow-up, and the difference between the two time points will be used to assess the effect of the intervention on patients' weight status. The change will be expressed as percent change of weight 3 months compared to baseline weight.

Trial sites (4)

Facility	City	Region	Status
Gauhati Medical College	Guwahati	Assam	Recruiting
Asian Institute of Gastroenterology Hospitals, Gachibowli	Hyderabad	Telangana	Recruiting
Asian Institute of Gastroenterology, Banjara Hills	Hyderabad	Telangana	Recruiting
ILS Hospital, Dum Dum	Kolkata	West Bengal	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07441824 on ClinicalTrials.gov ↗ ← All trials in India