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. 2018 Sep;32(5):1591-1599.
doi: 10.1111/jvim.15235. Epub 2018 Sep 17.

Randomized placebo controlled clinical trial of an enteric coated micro-pelleted formulation of a pancreatic enzyme supplement in dogs with exocrine pancreatic insufficiency

Joseph Cyrus Parambeth  1 , Geoffrey T Fosgate  2 , Jan S Suchodolski  1 , Jonathan A Lidbury  1 , Jörg M Steiner  1
Affiliations

Randomized placebo controlled clinical trial of an enteric coated micro-pelleted formulation of a pancreatic enzyme supplement in dogs with exocrine pancreatic insufficiency

Joseph Cyrus Parambeth et al. J Vet Intern Med. 2018 Sep.

Abstract

Background: Pancreatic enzyme supplements for the treatment of exocrine pancreatic insufficiency (EPI) in dogs can be uncoated or enteric coated. Enteric coated supplements might be advantageous.

Hypothesis/objectives: Enteric coated enzyme supplements are superior to uncoated supplements in dogs with clinical EPI.

Animals: Eleven dogs with naturally occurring EPI that were apparently free from other diseases.

Methods: Randomized, blinded, controlled cross-over clinical trial comparing a novel micro-encapsulated enteric coated enzyme supplement to a commercially available uncoated product in dogs with clinical EPI. Search of serum canine serum trypsin-like immunoreactivity concentration ≤ 2.5 µg/L in the Gastrointestinal Laboratory database was used to identify dogs with EPI.

Results: There was no difference -4.46% (95% CI: -7.97%--0.96%; P = .15) in the % acid hydrolysis fecal fat (primary outcome) between the enteric coated formulation (median: 11.8%; range 6.4%-17.0%) and the uncoated pancreatic enzyme replacement product (median: 17.5%; range: 5.2%-24.9%) in the 11 dogs that completed the study. Other variables did not differ between treatments.

Conclusions and clinical importance: This study, which had low statistical power, did not detect a difference between formulations.

Keywords: EPI; enteric coating; randomized clinical trial.

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Figures

Figure 1
Figure 1
Case flow indicating how the study was executed
Figure 2
Figure 2
Percentage AH fecal fat in the 11 dogs during the baseline (enrollment) and 2 periods of enzyme replacement with enteric coated and uncoated treatments. The star and hexagon points represent dogs with EPI who had no previous pancreatic enzyme supplement before enrollment into the study. The dotted line represents the median for that period
See this image and copyright information in PMC

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