Published study results can be found here.

Study Start Date: 10/01/2007
Study End Date: 12/31/2008

Azodyl in Renal Failure Trial (ART): A Pilot Study

Chronic renal failure (chronic kidney disease) is a debilitating condition commonly seen in older cats. Clinical signs are often ascribed to uremia, which is, in turn, correlated with azotemia (increased nitrogen waste products).

Azodyl is a probiotic/prebiotic medication that contains 3 lyophilized bacteria and a nutrient that promotes growth of these bacteria. The 3 bacteria metabolize ammonia and urea within the GI tract, thereby decreasing the patient's azotemia and potentially improving clinical signs. Azodyl is given in an enteric-coated capsule to allow release of the bacteria into the small intestine. However, clients are often unable to administer capsules to cats, and resort to sprinkling contents onto food. There is concern that this method of administration would inactivate the active ingredients by exposure to oxygen and gastric acid.

ART pilot study will examine whether sprinkling of Azodyl capsule contents provides any reduction in azotemia, when compared with a placebo. If pilot study data are encouraging, a large-scale clinical trial will be initiated.

Study Design:
Prospective randomized placebo-controlled double-blinded study

Sample Size:
Pilot study = 10-15 cats

Inclusion criteria:
See ART homepage for more details.
Owners and veterinarians should have computer access to provide patient updates online.

Exclusion Criteria:
See ART homepage for more details.

Study Controls:
Placebo-administered cats.

Study Endpoint(s):
2 months of therapy with Azodyl or placebo.

Samples:
Veterinarians will be required to submit 4 blood samples over a 3 month period. Blood sampling packs will be provided to each investigator. See protocol on the ART site for more information. Client consent forms can be downloaded for submission at the ART website.

Costs/Reimbursements:
Shipping and blood collection packs will be provided. Participating veterinary practices will be given a copy of the VSPN Notebook at the conclusion of their portion of the study (value $55).

Full Disclosure information:

• The study is funded by a grant from VIN Foundation.
• The investigators do not have any conflict of interest.
• The study will be published if results are negative.
• The study will be reported on VIN.
• The authors will acknowledge VIN if the study is published.