- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450670
Observational Study of Kibow Biotics in Dialysis Patients
Observational Clinical Trials of Kibow Biotics (a Patented and Proprietary Probiotic Dietary Supplement) in Dialysis Patients, in Conjunction With Standardized Care of Treatment
Study Overview
Status
Conditions
Intervention / 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. 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dialysis patients
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
15-20% Changes in BUN.
Time Frame: 12 months
|
12 months
|
15-20% Changes in Creatinine
Time Frame: 12 months
|
12 months
|
15-20% Changes in CRP
Time Frame: 12 Months
|
12 Months
|
15-20% Change in Uric Acid Levels
Time Frame: 12 Months
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life outcome based on SF 36 questionnaire.
Time Frame: 12 months
|
12 months
|
|
To observe inflammatory and oxidative stress biomarkers.
Time Frame: 12 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie DeLoach, M.D., Thomas Jefferson University, Philadelphia, PA
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KIB003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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