Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
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|ClinicalTrials.gov Identifier: NCT01450709|
Recruitment Status : Unknown
Verified May 2012 by Kibow Biotech Inc..
Recruitment status was: Recruiting
First Posted : October 12, 2011
Last Update Posted : May 3, 2012
|Condition or disease||Intervention/treatment|
|Chronic Kidney Disease||Dietary Supplement: Kibow Biotics|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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 Start Date :||April 2011|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||October 2012|
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).
- 15-20% Changes in BUN. [ Time Frame: 6 months ]
- 15-20% Changes in Creatinine [ Time Frame: 6 months ]
- 15-20% Changes in CRP [ Time Frame: 6 months ]
- 15-20% Changes in Uric Acid Levels [ Time Frame: 6 months ]
- Quality of life outcome based on SF 36 questionnaire. [ Time Frame: 6 months ]
- To observe inflammatory and oxidative stress biomarkers. [ Time Frame: 6 months ]Observe inflammatory markers IL-1beta, NF-kappaB, Protein Bound Pentosidine, Beta2 Microglobulin, Indoxyl sulfate, Phenols, p-cresols, and guanadine metabolites from blood serum.
- Observation and analysis of patient fecal matter. [ Time Frame: 6 months ]Observation and analysis of patient fecal matter to determine bacterial flora levels that are present in the stool.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450709
|Contact: Subodh J Saggi, M.D., MPHfirstname.lastname@example.org|
|United States, New York|
|Parkside Dialysis Clinic at Downstate Medical Center||Recruiting|
|Brooklyn, New York, United States, 11226|
|Principal Investigator: Subodh J Saggi, M.D., MPH|
|Principal Investigator:||Subodh J Saggi, M.D., MPH||Downstate Medical Center|
|Principal Investigator:||Mary Mallapallil, M.D.||Kings County Medical Center|
|Principal Investigator:||Eli Friedman, M.D., MACP, FRCP||Downstate Medical Center|
|Principal Investigator:||Gary Briefel, M.D.||Kings County Medical Center|