Clinical trial NCT01450709: Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
Official title: Observational Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Dialysis Patients, in Conjunction With Standardized Care of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Probiotics
Kibow Biotics
Dialysis
Gut based uremic toxin removal
Lead sponsor: Kibow Pharma
Sponsor class: INDUSTRY
Collaborators: name: State University of New York - Downstate Medical Center
First posted: 2011-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Out patient hospital setting

Brief summary: A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.

Detailed description: Probiotics are increasingly utilized clinically. As their safety and health benefits are established, it is reasonable to anticipate that probiotic bacteria will be incorporated into a growing number of clinical regimens, as a dietary supplement.

Extensive in vitro R\&D investigations in Kibow's laboratories

Bacterial strains studied were a mixture of patented and proprietary strains of Streptococcus thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).

Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University, Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr) levels.

Two independent veterinarians investigated the effect of Kibow Biotics® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA.

Pilot scale studies, double blind, placebo controlled, cross-over studies for six months conducted in 45 patients in USA, Canada, Argentina, and Nigeria demonstrates reduction of BUN (P\>95%) and improved quality of life (P\>95%). Decrease in creatinine and uric acid levels were also observed. However, these studies were based on correlating the age of geriatric cats and dogs with moderate to significant kidney failure to human geriatric conditions.

Eligibility criteria: Inclusion Criteria:

* Currently on hemodialysis
* 18 to 75 years of age
* Willing to give informed consent
* Baseline serum creatinine \>2.5 mg/dL

Exclusion Criteria:

* Pregnant or nursing women
* Refusal to sign the informed consent form
* Documented to have HIV/AIDS/Liver disease
* Active dependency on drugs or alcohol
* Currently on anticoagulant therapy

Primary outcomes:
measure: 15-20% Changes in BUN.
timeFrame: 6 months
measure: 15-20% Changes in Creatinine
timeFrame: 6 months
measure: 15-20% Changes in CRP
timeFrame: 6 months
measure: 15-20% Changes in Uric Acid Levels
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life outcome based on SF 36 questionnaire.
timeFrame: 6 months
measure: To observe inflammatory and oxidative stress biomarkers.
timeFrame: 6 months
measure: Observation and analysis of patient fecal matter.
timeFrame: 6 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Parkside Dialysis Clinic at Downstate Medical Center
state: New York
Study officials:
affiliation: Downstate Medical Center
name: Subodh J Saggi, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kings County Medical Center
name: Mary Mallapallil, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Downstate Medical Center
name: Eli Friedman, M.D., MACP, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Kings County Medical Center
name: Gary Briefel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranganathan N, Friedman EA, Tam P, Rao V, Ranganathan P, Dheer R. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada. Curr Med Res Opin. 2009 Aug;25(8):1919-30. doi: 10.1185/03007990903069249.
citation: Ranganathan N, Ranganathan P, Friedman EA, Joseph A, Delano B, Goldfarb DS, Tam P, Rao AV, Anteyi E, Musso CG. Pilot study of probiotic dietary supplementation for promoting healthy kidney function in patients with chronic kidney disease. Adv Ther. 2010 Sep;27(9):634-47. doi: 10.1007/s12325-010-0059-9. Epub 2010 Aug 16.