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Observational Study of Kibow Biotics in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT01450670
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
Sponsor:
Collaborator:
Thomas Jefferson University
Information provided by (Responsible Party):
Kibow Biotech Inc.

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 dialysis along with standardized care of treatment.

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

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 : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Dialysis patients 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.



Primary Outcome Measures :
  1. 15-20% Changes in BUN. [ Time Frame: 12 months ]
  2. 15-20% Changes in Creatinine [ Time Frame: 12 months ]
  3. 15-20% Changes in CRP [ Time Frame: 12 Months ]
  4. 15-20% Change in Uric Acid Levels [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Quality of life outcome based on SF 36 questionnaire. [ Time Frame: 12 months ]
  2. 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.


Biospecimen Retention:   Samples With DNA
Blood serum and plasma.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Out patient hospital setting
Criteria

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

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): NCT01450670


Contacts
Contact: Stephanie DeLoach, M.D. 215-955-1301 stephanie.deloach@jefferson.edu
Contact: Bonita Falkner, M.D. 215-503-2500 bonita.falkner@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Stephanie DeLoach, M.D.         
Sub-Investigator: Bonita Falkner, M.D.         
Sponsors and Collaborators
Kibow Biotech Inc.
Thomas Jefferson University
Investigators
Principal Investigator: Stephanie DeLoach, M.D. Thomas Jefferson University, Philadelphia, PA

Publications of Results:
Responsible Party: Kibow Biotech Inc.
ClinicalTrials.gov Identifier: NCT01450670     History of Changes
Other Study ID Numbers: KIB003
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012

Keywords provided by Kibow Biotech Inc.:
Probiotics
Kibow Biotics
Dialysis
Gut based uremic toxin removal

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic