Pancreatic enzyme replacement for recovery after severe necrotizing pancreatitis
Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial
This trial will test whether taking pancreatic enzyme capsules helps adults (18–60) with acute necrotizing pancreatitis who have lost at least 5% of their weight and have >50% pancreatic necrosis regain weight over three months compared with placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 4 sites (Guwahati, Assam and 3 other locations) |
| Trial ID | NCT07441824 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, double-blind, placebo-controlled randomized trial comparing oral pancreatic enzyme capsules (containing 25,000 IU lipase) to a matching placebo in a 1:1 ratio. Eligible adults with acute necrotizing pancreatitis, substantial pancreatic parenchymal necrosis (>50%) and recent weight loss will start treatment within six weeks of disease onset and must be able to take food orally. The primary outcome is percent change in body weight at three months after enrollment, with the aim of addressing malabsorption from pancreatic exocrine insufficiency that commonly follows necrosis. The trial is being conducted at sites in India and uses standard clinical care alongside the blinded study medication.
Who should consider this trial
Good fit: Adults aged 18–60 with an index episode of acute necrotizing pancreatitis involving more than 50% pancreatic necrosis, at least 5% loss of pre-pancreatitis body weight, within six weeks of disease onset, and able to tolerate oral intake are ideal candidates.
Not a fit: Patients with underlying chronic pancreatitis, recurrent acute pancreatitis, pancreatic cancer, those discharged with nasojejunal tubes, pregnant or lactating individuals, or those unable to consent are not expected to benefit from this trial.
Why it matters
Potential benefit: If successful, the intervention could help patients regain weight and reduce malnutrition and related complications from pancreatic exocrine insufficiency after acute necrotizing pancreatitis.
How similar studies have performed: Pancreatic enzyme replacement is an established therapy for chronic pancreatic exocrine insufficiency, but randomized controlled data specifically in acute necrotizing pancreatitis are limited, making this a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guwahati, Assam and 3 other locations
- Gauhati Medical College — Guwahati, Assam, India (Recruiting)
- Asian Institute of Gastroenterology Hospitals, Gachibowli — Hyderabad, Telangana, India (Recruiting)
- Asian Institute of Gastroenterology, Banjara Hills — Hyderabad, Telangana, India (Recruiting)
- ILS Hospital, Dum Dum — Kolkata, West Bengal, India (Recruiting)
Study contacts
- Study coordinator: Abdul Rasheed, PharmD
- Email: abdulrasheedmd1223@gmail.com
- Phone: +919652104726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.