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Digestive enzyme replacement in patients with damage to the pancreas due to inflammation

Effect of pancreatic enzyme replacement therapy on nutrition in acute necrotizing pancreatitis: a multicenter, double-blinded, randomized, placebo controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106827
Enrollment
140
Registered
2026-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Pancreatic enzyme replacement therapy: Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These medications are to be taken thrice daily with f

Sponsors

Asian Institute of Gastroenterology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria -Index episode of acute pancreatitis with at least 50% pancreatic parenchymal necrosis and greater than at least 5% loss of pre pancreatitis body weight at the time of screening -Within 28 days of onset of disease

Exclusion criteria

Exclusion criteria: -Underlying chronic pancreatitis. -Recurrent acute pancreatitis. -Pancreatic cancer. -Patients being discharged with NJ tubes. -Pregnancy and lactation. -Inability to give informed consent.

Design outcomes

Primary

MeasureTime frame
Percentage Change in Body Weight.Timepoint: 3 months

Secondary

MeasureTime frame
Change in Nutritional StatusTimepoint: 3 months;Change in Quality of LifeTimepoint: 3 months;Change in exocrine functionTimepoint: 3 months;Change in endocrine functionTimepoint: 3 months;Patient s Global Impression of Change (PGIC) StatusTimepoint: 3 months;Readmissions During the Study PeriodTimepoint: 3 Months;Change in body compositionTimepoint: 3 months

Countries

India

Contacts

Public ContactRupjyoti Talukdar

Asian Institute of Gastroenterology, Gachibowli, Hyderabad

rup_talukdar@yahoo.com7032804231

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026