Clinical proof of concept study to evaluate the safety of Crofelemer (PS-303) in dogs with chemotherapy-induced diarrhea

Purpose of Study: 

The usual treatment of chemotherapy-induced diarrhea is medical therapy such as, metronidazole, withholding food, and stopping the chemotherapy treatment until the diarrhea is resolved, usually in 3-5 days. Crofelemer is a sustainably harvested, (meaning for every tree that is used, another is planted in its place) purified extract of the Croton lechleri tree found in the Amazon region. Preliminary studies suggest crofelemer is effective in relieving acute diarrhea of many causes in dogs, but it has been tested in a limited number of dogs with chemotherapy-induced diarrhea.

The purpose of this study is to assess the safety of crofelemer (SP-303) for the treatment of chemotherapy-induced diarrhea in dogs. The goal of therapy is to improve fecal consistency and reduce the number of days with diarrhea so your dog’s quality of life is improved and the prescribed chemotherapy treatments are not delayed

Eligibility: 
  1. Dogs currently experiencing diarrhea while being treated with a prescribed anticancer chemotherapy protocol.
  2. Dogs should be greater than 1 year of age, weigh at least 5 lbs, have at least one loose bowel movement with a semi-formed or pudding-like consistency stool, and currently receiving chemotherapy for cancer treatment.
  3. Pre-treatment screening will consist of a physical examination and blood tests (CBC, chemistry panel, free catch urinalysis).  
Exclusion: 

1. Dogs may not be pregnant, lactating, or intended for breeding.
2. Dogs must be eating at the time of study entry.

Client Responsibilities: 
  1. Oral administration of crofelemer twice daily approximately 12 hours apart (total of 14 doses).
  2. Completion of a daily diary denoting time and date of dose administration, mealtime, fecal scores (will be discussed with you at the start of the study), any new or old medications given to your dog during the study.
  3. Maintenance of your dog’s regular diet at home.
  4. Return to study site within 2 calendar days after the 7-day treatment period for patient re-evaluation and review of the diary.
Client Benefits: 
  1. You do not pay for your dog’s participation in the study; however, you will continue to be responsible for any costs associated with the normal course of prescribed anticancer treatment.
  2. Fifty dollars will be credited to your dog’s hospital bill on the final visit to ISU.
Contact: 

Dr Leslie Fox: 515-294-4900

Dr Chad Johannes: 515-294-4900