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Observational Study of Kibow Biotics in Chronic Kidney Failure Patients

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ClinicalTrials.gov Identifier: NCT01450657
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
Thomas Jefferson University
Information provided by (Responsible Party):
Kibow Pharma

Study Description
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Brief 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 standardized care of treatment for their CKD stage 3 and stage 4 conditions.

Condition or disease Intervention/treatment
Chronic Kidney Failure Dietary Supplement: Kibow Biotics/Renadyl

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 Design
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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : July 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
Chronic Kidney Failure 3/4 Dietary Supplement: Kibow Biotics/Renadyl
Month 1, one capsule three times daily (90 colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3 & 4, three capsules three times daily (270 CFU's). Months 5 & 6 are washout periods, in which the patient receives no product. All parameters are still monitored by the study site during months 5 & 6. All medical, physical, clinical, QOL and other parameters will be monitored as well.
Other Name: Kibow Biotics


Outcome Measures
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Primary Outcome Measures :
  1. 15-20% Changes in BUN. [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months. ]
  2. 15-20% Change in Creatinine [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months ]

Secondary Outcome Measures :
  1. Quality of life outcome based on questionnaire. [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months ]
  2. To observe inflammatory and oxidative stress biomarkers. [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months ]
    Observe inflammatory and stress markers in metabolites from blood serum.

  3. Observation and analysis of patient fecal matter. [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 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
Blood plasma and serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatient hospital setting.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01450657


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Kibow Pharma
Thomas Jefferson University
Investigators
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Principal Investigator: Stephanie DeLoach, M.D. Thomas Jefferson University, Philadelphia, PA
More Information
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Publications of Results:

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Responsible Party: Kibow Pharma
ClinicalTrials.gov Identifier: NCT01450657    
Other Study ID Numbers: KIB002
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Keywords provided by Kibow Pharma:
Chronic Kidney failure stage three and four
Probiotics
Kibow Biotics
Dialysis
Gut based uremic toxin removal
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic