Chronic Kidney FailureProbioticsNCT00760162
Pilot-Scale Clinical Trials of Kibow Biotics® in Chronic Kidney Failure
An observational study of Chronic Kidney Failure, run by Kibow Pharma at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Failure
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out patient Hospital setting
Who may be able to join
- CKD patients Stage III and IV
- 18 to 75 years old, able and willing to give an informed consent
- Baseline serum creatinine > 2.5 mg/dL
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Downstate Medical Center,HSCB, State University of New York
Brooklyn, New York, 11203
SUNY DownState Medical Center-Renakl Division
Brooklyn, New York, 11203
About this study
Official title: Pilot-Scale Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Chronic Kidney Failure
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
Read the 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.
Following exploratory testing of orally administered probiotic bacteria in rats and minipigs with surgically induced chronic kidney disease (CKD), a trial is now in progress to determine whether daily treatment with gastrointestinal (GI) probiotic bacteria will delay the onset of and/or improve established signs and symptoms of human CKD.
To assess the potential benefit in devising a gut-based probiotic formulation (Kibow Biotics®) as a dieatary supplement - Over The Counter (OTC)product in CKD applications.
Extensive in vitro R\&D investigations in Kibow's laboratories
Simulated Human Intestinal Microbial Ecosystem (SHIME, Ghent University, Belgium) utilized in a computer-controlled in vitro system validated the concept that the chosen microbial formulation would metabolize and reduce concentration of nitrogenous components including urea, creatinine, and uric acid. Bacterial strains studied were 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® on clinically manifested renal failure in uremic cats and dogs of both genders and varying body weights. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA
- Conditions
- Chronic Kidney Failure
- Keywords
- Chronic Kidney failure stage three and four, Probiotics, Kibow Biotics, Enteric Dialysis, Gut based removal uremic toxin removal
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid
Measured: six months
Changes in BUN, Creatinine and uric acid levels
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kibow Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eli A Friedman, MD, Study chair, Downstate Medical Center - State University of New York, Brooklyn, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760162
- Sponsor's protocol ID
- KIB001
- Acronym
- Probiotics
- Status last verified
- Aug 2019
- First submitted
- 25 Sep 2008
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37870148Ranganathan 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.
PubMed 19558344
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-Scale Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Chronic Kidney Failure
- ClinicalTrials.gov ID
- NCT00760162
- Acronym / sponsor ID
- Probiotics / KIB001
- Conditions
- Chronic Kidney Failure
- Keywords
- Chronic Kidney failure stage three and four, Probiotics, Kibow Biotics, Enteric Dialysis, Gut based removal uremic toxin removal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Kibow PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Following exploratory testing of orally administered probiotic bacteria in rats and minipigs with surgically induced chronic kidney disease (CKD), a trial is now in progress to determine whether daily treatment with gastrointestinal (GI) probiotic bacteria will delay the onset of and/or improve established signs and symptoms of human CKD.
To assess the potential benefit in devising a gut-based probiotic formulation (Kibow Biotics®) as a dieatary supplement - Over The Counter (OTC)product in CKD applications.
Extensive in vitro R\&D investigations in Kibow's laboratories
Simulated Human Intestinal Microbial Ecosystem (SHIME, Ghent University, Belgium) utilized in a computer-controlled in vitro system validated the concept that the chosen microbial formulation would metabolize and reduce concentration of nitrogenous components including urea, creatinine, and uric acid. Bacterial strains studied were 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® on clinically manifested renal failure in uremic cats and dogs of both genders and varying body weights. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out patient Hospital setting
Key inclusion criteria (3 listed)
- CKD patients Stage III and IV
- 18 to 75 years old, able and willing to give an informed consent
- Baseline serum creatinine > 2.5 mg/dL
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid
Time frame: six months
Changes in BUN, Creatinine and uric acid levels
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Derived from this study: PubMed 37870148Cooper 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.
- Derived from this study: PubMed 19558344Ranganathan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli A Friedman, MD study chair
Downstate Medical Center - State University of New York, Brooklyn, NY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Failure, run by Kibow Pharma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00760162, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.