Observational Study of Kibow Biotics in Dialysis Patients

Chronic Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450670
• Other study ID #: KIB003
• Status: Completed
• Start date: May 2011
• Est. completion date: July 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. The proposed current study is being reevaluated based on correlating the weight basis of animal to human conditions. Hence, this is a does escalation study on ingestion of 1x (90 billion CFU/day), 2x (180 billion CFU/day), and 3x (270 billion CFU/day) dosages.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: June 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 Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Dietary Supplement:
• Kibow Biotics
Month 1, one capsule three times daily (90 Colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3, three capsules three times daily (270 CFU's). Continued on tolerated maintenance dosage for an additional 6 months. Once tolerated dosage is identified the patient will be continued on that maintenance dosage for an additional 6 months. All medical, physical, clinical, QOL and other parameters will be monitored as well.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Kibow Biotech Inc.	Thomas Jefferson University

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.		12 months
Primary	15-20% Changes in Creatinine		12 months
Primary	15-20% Changes in CRP		12 Months
Primary	15-20% Change in Uric Acid Levels		12 Months
Secondary	Quality of life outcome based on SF 36 questionnaire.		12 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.	12 months