Study Start Date: 01/01/2007
Study End Date: 01/06/2009

Clinical Study of Improved Management of Advanced Kidney Disease in Dogs Using an Intestinal-based probiotic

Purpose: Chronic kidney disease (CKD) is an important cause of morbidity and mortality in middle-aged and older dogs. It is generally regarded as a progressive disease culminating in uremia and death. Uremia results from accumulation in the blood of compounds normally excreted in urine. As the kidneys lose function in CKD, these compounds are progressively retained in the body. These wastes or "toxins" cause your pet to have a poor appetite, vomit, be lethargic and feel ill. Oral sorbents and selected probiotics may provide a viable means of managing uremia in dogs with advanced CKD. Sorbents and selected probiotics trap uremic wastes in the intestines and allow them to be removed in the feces. The purpose of this study is to determine if daily administration of an intestinal-based probiotic reduces signs of kidney disease and forestalls the onset of uremic signs. Standard laboratory monitoring will be conducted at regular intervals, and standardized "best practices" will be applied to management of kidney disease. Additionally, selected advanced physiological and functional assessments (e.g., bioimpedance spectroscopy, exogenous creatinine clearances, assessment of iron status, urea appearance measurements) will be used to assess response to therapy or placebo.

Study Design:
Prospective, Placebo-controlled, Randomized, Double-blinded

Sample Size:
48 dogs

Inclusion criteria:
This is a canine study only.
Np

1. Dog is greater than 1 year of age
2. Confirmed diagnosis of CKD
3. Serum creatinine concentrations (2) between 3.0 and 8.0 mg/dl
4. Nutrition score 3/9 or greater
5. Dog is not in overt uremic crisis
6. Owner provides consent for feeding tube placement if needed to maintain body weight
7. Dog is not expected to die of another illness during study.
8. Patients can be presented to one of the participating institutions for evaluation:
   1. University of Minnesota Veterinary Medical Center (David Polzin)
   2. UC Davis Veterinary Medical Teaching Hospital (Larry Cowgill)
   3. UC Veterinary Medical Center-San Diego (Sheri Ross, Julie Fischer)
   4. Animal Medical Center, Manhattan, NYC (Catherine Langston)

Exclusion Criteria:
1. Diabetes mellitus
2. Hyperadrenocorticism
3. Systemic lupus erythematosus
4. Chronic corticosteroid therapy

This is a randomized, double-blinded and placebo-controlled study.

Costs/Reimbursements:
The study will cover the costs related to performing the study with the exception of feeding tube placement if necessary. This includes routine examinations, blood pressure measurements, blood and urine samples as scheduled. We will also provide a renal diet (Hill's k/d) at no cost for the duration of the study. In addition, we will provide the probiotic or placebo used during the study. We will not cover the costs of any additional diagnostic tests or treatments that may be required in the care of your pet. We will make treatment recommendations based on our opinion of the best treatments for your pet, however, you may decide to accept or reject our recommendations. The study will not cover costs related to development of signs of uremia or kidney disease beyond the tests and treatment provided by the study protocol and specifically identified above. There are no cash incentives provided for participation in this study.

Full Disclosure information:

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