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The purpose of this clinical study is to determine the effect of a test diet on the management of idiopathic Inflammatory Bowel Disease (IBD) in dogs.
Clinical Study Overview
Ø Study is conducted in 2 phases:
o Phase I: 3-week food elimination trial
o Phase II: Dogs not showing resolution in phase I will be evaluated for inclusion for Phase II
Ø All dogs entering Phase II will received a standardized medical regimen for IBD in addition to being fed the Test diet or a positive control diet.
Ø Reimbursement is offered for minimum data base and 2 endoscopic examinations and histopathological evaluations:
Ø Dogs will be evaluated by Florida Veterinary Specialists at weeks 0, 3, 7, 11 during Phase I and Phase II.
Ø Enrollment will begin June 2005 and continue for 4 months
A dog is eligible for participation in Phase I of the study, if the dog:
1. Is greater than 1-year of age
2. History of chronic diarrhea for a minimum of 3 weeks
3. Exclusion of other causes of chronic diarrhea including but not limited to exocrine pancreatic insufficiency, parasitism, infectious disease (fungal, bacterial, and viral), protein losing enteropathy, gastrointestinal neoplasia, histiocytic colitis, or drug-associated (e.g. NSAID’s, antibiotics, cancer chemotherapeutics) causes.
Client incentives
o Up to 100% of diagnostics to determine eligibility and treatment response will be covered by sponsor
o $25 per patient for each examination
o $250 per patient for study completion (requires submission of completed documentation)
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