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Completed

NCT Number: NCT01450670

Observational Study of Kibow Biotics in Dialysis Patients

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.

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Key information

Conditions

Chronic Kidney Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kibow Biotics

Dietary Supplement

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kibow Pharma

Industry

Collaborators

  • Thomas Jefferson University

Registry information

Official study title

Observational Clinical Trials of Kibow Biotics (a Patented and Proprietary Probiotic Dietary Supplement) in Dialysis Patients, in Conjunction With Standardized Care of Treatment

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 12, 2011
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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