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Enzyme Replacement Therapy

Pancreatic Enzyme Replacement Therapy for Pancreatic Insufficiency (PERT-AP Trial)

Phase 4
Recruiting
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase)
Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage)
Must not have
History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline
Gastroparesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 210 days
Awards & highlights

Summary

This trial aims to see if taking pancrelipase (CREON) for 6 months can help improve symptoms of exocrine pancreatic insufficiency after an acute pancreatitis attack. Patients with low fec

Who is the study for?
This trial is for individuals who have had an acute pancreatitis attack and are now experiencing symptoms of exocrine pancreatic insufficiency (EPI), confirmed by a fecal elastase test showing less than 200. Participants should be willing to take pancrelipase capsules for six months and complete health surveys.
What is being tested?
The study tests whether taking pancrelipase (CREON) for six months can improve EPI symptoms following acute pancreatitis. It involves regular blood and stool tests, as well as completing surveys to monitor symptom changes over the treatment period.
What are the potential side effects?
Possible side effects of taking pancrelipase may include gastrointestinal discomfort such as gas, bloating, constipation or diarrhea, nausea, abdominal cramps, and hypersensitivity reactions if allergic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight is between 40 and 120 kg.
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I have completed treatment for severe pancreatitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a confirmed history of chronic pancreatitis.
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I have been diagnosed with gastroparesis.
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I have had surgery on my pancreas or upper GI tract.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~210 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 210 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-Reported EPI Symptoms - Short Term
Secondary outcome measures
Change in Depression Score
Change in Global Health Score
Change in Nutrition Biomarkers - Albumin
+6 more
Other outcome measures
Change in Stool Consistency
Change in Stool Frequency
Frequency, Type, and Severity of Adverse Events
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PancrelipaseExperimental Treatment1 Intervention
Pancrelipase (CREON) capsules taken orally with food, at a dose 36,000 units with snacks and 72,000 units with meals, for a total of 6 months (180 days)

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaOTHER
936 Previous Clinical Trials
1,613,421 Total Patients Enrolled
University of Illinois ChicagoUNKNOWN
Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,705 Total Patients Enrolled
~40 spots leftby Dec 2026
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