Spascupreel™ in Canine IBD Clinical Trial

Species: 
Dog
Area of Study: 
Internal Medicine

Purpose of Study: 

In this study, we want to evaluate the clinical efficacy of a new product (Spascupreel) in dogs with chronic diarrhea (enteropathy).

Spascupreel™ contains a combination of herbal medicines, which may reduce and control abdominal pain in chronic diarrhea cases. This medication is unlikely to cause any unwanted side effects but may significantly reduce abdominal pain associated with IBD in your dog.

The purpose of this study is to compare the outcome of 2 groups of dogs with chronic enteropathy:

  • One group treated with hypoallergenic diet, together with Spascupreel™
  • One group treated with hypoallergenic diet and a placebo (containing no medication).
  • If your dog does not get better on diet alone, rescue treatment with cyclosporin (5mg orally once a day for 6 weeks) will be initiated.

Cyclosporine and hypoallergenic diet are each part of the standard management of chronic enteropathy (IBD) in a dog.

Eligibility: 

Dogs with chronic enteropathy, eg. vomiting, diarrhea, poor appetite over 3 weeks

Dogs body weight >/=2kg and > 1 year of age

Antibiotics, immunosuppressives, and NSAIDs, have been discontinued for at least 7 days

Exclusion diagnosis for workup of IBD

CCECAI score >5

Fecal score >3

History of abdominal bloating and/or pain

 

Exclusion: 

Dogs' body weight < 2 kg
Diagnosis of additional diseases to IBD
Antibiotics, immunosuppressives, and NSAIDs, have not been discontinued for at least 7 days
CCECAI score </=5
Fecal score </=3
No history of abdominal bloating and/or pain

Client Responsibilities: 

If you agree to have your animal participate in this study, the participation will include 2 additional visits at the Lloyd Veterinary Medical Center, over a 6 week-period.  

The visits will occur as follows:

  • Visit 1: Day of enrollment.

Your dog will be randomly assigned to one of the 2 groups mentioned above.

This visit will occur as follows:

  • A Quality of Life Questionnaire (QoL) will be filled in.
    • The following samples will be collected for the study:
      • Blood: about 3mL of blood will be sampled (about half a tablespoon).
      • Feces will be collected from a voided sample.
    • An hypoallergenic diet will be provided for the entire study period.

All of the above, including the diet, is part of routine management of a dog with chronic enteropathy, regardless of the study.

  • Visit 2: Week 2
  • On this visit, blood and feces will be collected again for the study, as described above. A Quality of Life Questionnaire (QoL) will be filled in.
  • Visit 3: Week 6
  • On this visit, blood and feces will be collected again for the study, as described above. A Quality of Life Questionnaire (QoL) will be filled in.

If your dog does not show significant improvement of their condition at Visit 2, they will be prescribed cyclosporine (immuno-suppressive medication) and will remain enrolled in the study for the full 6 weeks course.

Client Benefits: 

Each study participant will receive a free 6-week Purina HA diet and a study participation credit of $900 off the total bill after completion of the third visit.

You will be responsible for any costs associated with the normal course of diagnostic testing, which may include endoscopy, treatment, and unrelated medical conditions.

Contact: 

You are encouraged to ask questions at any time during this study.  For further information about the study,

contact Dr. Merodio Maria (mmaria@iastate.edu) or Dr. Megan Posukonis (515-294-4900).