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

Chronic Kidney Disease Clinical Trial

Official title:

Observational Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Dialysis Patients, in Conjunction With Standardized Care of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450709
• Other study ID #: KIB004
• Status: Completed
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: August 2019
• Source: Kibow Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Kibow Biotics
6 month, double-blind, cross-over, wash-out, placebo controlled study in an outpatient setting. Each patient takes two capsules, three times a day (180 CFU/day).

Locations

Country	Name	City	State
United States	Parkside Dialysis Clinic at Downstate Medical Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
Kibow Biotech Inc.	State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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: 10.1185/03007 — View 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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	15-20% Changes in BUN.		6 months
Primary	15-20% Changes in Creatinine		6 months
Primary	15-20% Changes in CRP		6 months
Primary	15-20% Changes in Uric Acid Levels		6 months
Secondary	Quality of life outcome based on SF 36 questionnaire.		6 months
Secondary	To observe inflammatory and oxidative stress biomarkers.	Observe inflammatory markers IL-1beta, NF-kappaB, Protein Bound Pentosidine, Beta2 Microglobulin, Indoxyl sulfate, Phenols, p-cresols, and guanadine metabolites from blood serum.	6 months
Secondary	Observation and analysis of patient fecal matter.	Observation and analysis of patient fecal matter to determine bacterial flora levels that are present in the stool.	6 months