Observational Study of Kibow Biotics in Chronic Kidney Failure Patients
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | July 2011 |
| End Date: | October 2012 |
| Contact: | Stephanie DeLoach, M.D. |
| Email: | stephanie.deloach@jefferson.edu |
| Phone: | 215-955-1301 |
Observational Clinical Trials of Kibow Biotics (a Patented and Proprietary Probiotic Dietary Supplement) in Chronic Kidney Failure Patients, in Conjunction With Standardized Care of Treatment
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 standardized care
of treatment for their CKD stage 3 and stage 4 conditions.
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 standardized care
of treatment for their CKD stage 3 and stage 4 conditions.
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.
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.
Inclusion Criteria:
- Age 18 to 75 years
- CKD Stages 3 and 4 as documented by prior medical history
- Serum Creatinine >2.5 mg/dL
- Stable and on CKD status 3 and 4 at least for a year or more
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
- Any non-related medical, debilitating disease/disorder that would interfere with
adherence to this study
- Currently on anticoagulant therapy
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