Observational Study of Kibow Biotics in Dialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Kibow Biotech Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Thomas Jefferson University
Information provided by (Responsible Party):
Kibow Biotech Inc.
ClinicalTrials.gov Identifier:
NCT01450670
First received: September 26, 2011
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention
Chronic Kidney Failure
Dietary Supplement: Kibow Biotics

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kibow Biotech Inc.:

Primary Outcome Measures:
  • 15-20% Changes in BUN. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 15-20% Changes in Creatinine [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 15-20% Changes in CRP [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • 15-20% Change in Uric Acid Levels [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life outcome based on SF 36 questionnaire. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To observe inflammatory and oxidative stress biomarkers. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Kibow Biotech Inc.
ClinicalTrials.gov Identifier: NCT01450670     History of Changes
Other Study ID Numbers: KIB003
Study First Received: September 26, 2011
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014