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EPIC Study

The EPIC study: Exocrine Pancreatic Insufficiency Control Study

The EPIC study is a project that is seeking to evaluate if a novel diet can be as effective as the use of pancreatic enzyme replacement therapy at management of EPI in dogs.  We are currently enrolling dogs who have been diagnosed with EPI, receiving pancreatic enzyme replacement therapy (PERT), and have stable body weight. 

EPI is a condition resulting from the animal’s inability to produce sufficient pancreatic enzymes.  As a result, affected dogs may not be able to sufficient digest and absorb nutrients, especially fat.  The current standard of care therapy for dogs with EPI is the use of PERT administered with each meal.  PERT can be associated with challenges including significant cost to the owners, and side effects such as gingival bleeding and intolerance to pork protein.  Feeding a special diet containing kibble coated with hydrolyzed fat may be an alternative to the use of PERT, allowing fat absorption even in the absence of pancreatic enzymes. 

In this randomized, blinded, crossover, clinical trial, each dog will start on an acclimation diet and enzyme for 30 days.  After this initial period, each dog will start either on the test diet and a placebo enzyme or a control diet and control enzyme.  After a 30-day period, each dog will switch to the other study arm for 30 days.  Dogs will be fed a diet and enzymes provided by the study for a 90-day period and should not be fed anything else.  The dog owner and veterinarian will not know which diet and enzyme the dog is receiving at any point during the study. 

If you are interested, please fill out this interest survey at https://studypages.com/s/the-epic-exocrine-pancreatic-insufficiency-control-study-178536/?ref=gallery. 

Patient Eligibility

To be eligible, dogs must:

  • Have previously been diagnosed with EPI (TLI measurement <2.5) and had clinical signs at the time of diagnosis (weight loss, diarrhea, changes with appetite, etc.).
  • Be currently receiving pancreatic enzyme replacement therapy (PERT) with meals.
  • Have had stable body weight on their current PERT for at least 1 month. 
  • Be greater than 1 year of age.
  • Weigh more than 10 pounds (4.5kg) and have a body condition score (BCS) greater than 3/9.
  • Be willing to readily eat twice daily meals and PERT provided by the study.

Owners must:

  • Be willing to bring their dog to their veterinarian for a total of 6 visits over a 3-month period.  Dogs do NOT have to travel to Texas A&M University and can be seen at their primary care veterinarian. 
  • Be willing to exclusively feed the study diets and enzymes during the 3-month period. 
  • Be able to download an app on their mobile device and answer a daily questionnaire about their dog’s appetite and stool quality, as well as take a daily picture of the feces during the entire study period.

Duration of the Study

  • The duration of the study is 3.5 months (14 weeks) in total as follows:
    • Visit 1 (day 0)- exam, body weight, blood draw, collect voided feces, begin daily journal on app
    • Visit 2 (day 30)- exam, body weight, blood draw, collect voided feces
    • Visit 3 (day 45)- brief exam, body weight
    • Visit 4 (day 60)- exam, body weight, blood draw, collect voided feces
    • Visit 5 (day 75)- brief exam, body weight
    • Visit 6 (day 90)- exam, body weight, blood draw, collect voided feces
    • Continue journaling on app for 2 weeks following last visit

Required Samples: Owners will collect naturally voided feces at home prior to four of the veterinary visits.  Blood will be collected from each dog by the veterinarian at four of the veterinary visits. 

Client Incentives

We offer the following:

  • Enzymes and diet throughout the duration of the study
  • CBC, chemistry panel, and GI panel (TLI/PLI/Cobalamin/Folate) for four veterinary visits. 
  • The exam fee for each of the study visits will be paid for by the study. 
  • $250 gift card to each owner upon successful completion of the study

The owner will be responsible for costs other than the items listed above. 

Enrollment

Final enrollment is based on review of the medical records, followed by conversations with the owner and primary care veterinarian of each dog.

Please complete the initial interest survey at https://studypages.com/s/the-epic-exocrine-pancreatic-insufficiency-control-study-178536/?ref=gallery. 

Additional questions can be sent via email to epistudy@tamu.edu.