NCT01450670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

September 26, 2011

Last Update Submit

August 16, 2019

Conditions

Chronic Kidney Failure

Keywords

ProbioticsKibow BioticsDialysisGut based uremic toxin removal

Outcome Measures

Primary Outcomes (4)

  • 15-20% Changes in BUN.

    12 months

  • 15-20% Changes in Creatinine

    12 months

  • 15-20% Changes in CRP

    12 Months

  • 15-20% Change in Uric Acid Levels

    12 Months

Secondary Outcomes (2)

  • Quality of life outcome based on SF 36 questionnaire.

    12 months

  • To observe inflammatory and oxidative stress biomarkers.

    12 months

Study Arms (1)

Dialysis patients

Dietary Supplement: Kibow Biotics

Interventions

Kibow BioticsDIETARY_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.

Dialysis patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Out patient hospital setting

You may qualify if:

  • Currently on hemodialysis
  • to 75 years of age
  • Willing to give informed consent
  • Baseline serum creatinine \>2.5 mg/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

  • Ranganathan N, Friedman EA, Tam P, Rao V, Ranganathan P, Dheer R. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada. Curr Med Res Opin. 2009 Aug;25(8):1919-30. doi: 10.1185/03007990903069249.

    PMID: 19558344RESULT

  • Ranganathan N, Ranganathan P, Friedman EA, Joseph A, Delano B, Goldfarb DS, Tam P, Rao AV, Anteyi E, Musso CG. Pilot study of probiotic dietary supplementation for promoting healthy kidney function in patients with chronic kidney disease. Adv Ther. 2010 Sep;27(9):634-47. doi: 10.1007/s12325-010-0059-9. Epub 2010 Aug 16.

    PMID: 20721651RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum and plasma.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephanie DeLoach, M.D.

    Thomas Jefferson University, Philadelphia, PA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2011

First Posted

October 12, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

US(1)