NCT00760162

Brief Summary

The bowel can serve as a complement to the kidneys' excretory function A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been called "enteric dialysis"® Confirm the alleviation of uremic syndrome hypothesis Determine the outcome of probiotics treatment Confirm U.S. FDA's Generally Recognized As Safe (GRAS) status - if needed

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

2 active sites

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

August 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

September 25, 2008

Last Update Submit

August 16, 2019

Conditions

Chronic Kidney Failure

Keywords

Chronic Kidney failure stage three and fourProbioticsKibow BioticsEnteric DialysisGut based removal uremic toxin removal

Outcome Measures

Primary Outcomes (2)

  • PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid

    six months

  • Changes in BUN, Creatinine and uric acid levels

    six months

Study Arms (6)

HSCB, Brooklyn, NY

State University of New York Brooklyn, NY 11203

2. Nephrology Associates,

Scarborough, ON CANADA, LI H IC5

3.New York Harbor VA Medical Center

NYU School of Medicine New York, NY.10010

4.Hospital Juarez De Mexico

Madero, Mexico, D.FC.P. 07760

5. Hospital Italiano de Buenos Aires

Buenos Aires, Argentina.

6. National Hospital

Abuja, Nigeria

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:

  • CKD patients Stage III and IV
  • to 75 years old, able and willing to give an informed consent
  • Baseline serum creatinine \> 2.5 mg/dL

You may not qualify if:

  • Women who are pregnant or nursing
  • Patients who are on antibiotic treatment at the time of screening will be excluded from the study (Patients who have received antibiotics should have stopped them for at least 14 days prior to screening)
  • Patients who do not agree to sign the informed consent form
  • Active dependency on drugs or alcohol
  • Patients with documented Human Immunodeficiency Virus (HIV) infection/ Acquired Immunodeficiency Syndrome (AIDS)/Liver Disease
  • Any medical, psychiatric, debilitating disease/disorder or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent, or affect the overall prognosis of the patient
  • Patients who are on coumadin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Downstate Medical Center,HSCB, State University of New York

Brooklyn, New York, 11203, United States

Location

SUNY DownState Medical Center-Renakl Division

Brooklyn, New York, 11203, United States

Location

Related Publications (2)

  • Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.

    PMID: 37870148DERIVED

  • 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: 19558344DERIVED

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

  • Eli A Friedman, MD

    Downstate Medical Center - State University of New York, Brooklyn, NY

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

August 1, 2007

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

US(2)