Pancreatic enzyme replacement for recovery after severe necrotizing pancreatitis

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

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Endorotor versus standard endoscopic removal for walled-off pancreatic necrosis

  This trial will try whether using the Endorotor device helps adults with infected or symptomatic walled-off pancreatic necrosis recover faster or with fewer procedures than standard endoscopic necrosectomy after drainage.

  Recruiting Assistance Publique - Hôpitaux de Paris · Clichy · NCT07253350

• Removing the spleen with open debridement for necrotizing pancreatitis and left-sided portal hypertension

  This trial will test whether removing the spleen during open debridement helps adults with acute necrotizing pancreatitis and left-sided (sinistral) portal hypertension recover faster and with fewer complications than debridement alone.

  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07080697

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

  This study tests whether a microbial (fungal) pancreatic enzyme product can work as well as the standard porcine enzyme in adults with chronic pancreatitis and PEI.

  Recruiting Phase 3 Asian Institute of Gastroenterology, India · Hyderabad, Telangana · NCT07697352

• New lipase NHS7108 safety and potential efficacy in adults with exocrine pancreatic insufficiency

  A 2-period study tests whether the new lipase NHS7108 works safely for adults with EPI by comparing it to the standard pancrelipase (Zenpep) at several doses over 14 days each.

  Recruiting at 7 sites Phase 2 Société des Produits Nestlé (SPN) · Scottsdale, Arizona and 38 other locations · NCT07559175

• Detecting pancreatic dysfunction in adults with type 2 diabetes

  This project tests whether blood tests, a stool sample, and an ultrasound can identify pancreatogenic diabetes in adults with type 2 diabetes.

  Recruiting West Kazakhstan Marat Ospanov Medical University · Aktobe, Aktobe · NCT07512934

• ANG003 for pancreatic enzyme replacement in cystic fibrosis–related exocrine pancreatic insufficiency

  This trial will test whether ANG003, a new pancreatic enzyme replacement, works as well as Creon for people with cystic fibrosis who have exocrine pancreatic insufficiency.

  Recruiting at 21 sites Phase 2 Anagram Therapeutics, Inc. · Long Beach, California and 27 other locations · NCT07450547

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.