Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis

Kibow Pharma

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Kibow Biotics

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01450709

KIB004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Dialysis patients

Treatment:

Dietary Supplement: Kibow Biotics