Kidney Failure, ChronicPhase 2/3NCT03010735
Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)
A Phase 2/3 study testing probiotics in people with Kidney Failure, Chronic, run by China Agricultural University at 3 sites in China.
Trial summary
The purpose of this study is to investigate the effects of oral administration of probiotics on the metabolism of uremic toxins, in the patients with End Stage Renal Disease (ESRD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2015to Dec 2017
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- Patients who diagnosed as ESRD with hemodialysis
- Fixed hemodialysis cycle (average 3 times a week)
- Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.)
- Agree to sign the informed consent form
Who cannot join
- Taking antibiotics or antifungal drugs within 30 days before the study
- Have serious allergic reaction to skim milk powder
- Researcher are not sure whether the subjects are willing or able to complete the study
- Subject participated in other research projects within two months before the study
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Anzhen Hospital
Beijing, 100029
General Hospital of Chinese Armed Police Forces
Beijing, 100039
Peking University Aerospace Centre Hospital
Beijing, 100049
About this study
Official title: Effects of Probiotics on Metabolism of Uremic Toxin in Patients With End Stage Renal Disease (ESRD)
The purpose of this study is to investigate the effects of oral administration of probiotics on the metabolism of uremic toxins, in the patients with End Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also assessed.
- Conditions
- Kidney Failure, Chronic
- Being tested
- probiotics, Placebo
- Keywords
- Kidney Failure, Chronic, Probiotics, Uremic toxins, Gastrointestinal Microbiome
- 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.
probioticsDietary supplement
Daily take 4.0E+10 CFU of probiotics
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | The patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics. Receives: Dietary Supplement: probiotics |
| Placebo | Placebo comparator | The patient take two placebo chewing tablet per day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Microbiota-derived uremic toxin
follow up the patients at Month 0, 3, 6
Measured: 6 months
Secondary outcomes (7)
Changes in Fecal Microbiome
follow up the patients at Month 0, 3, 6
Measured: 6 months
Changes in Fecal metabolites
follow up the patients at Month 0, 3, 6
Measured: 6 months
Changes in Blood metabolites
follow up the patients at Month 0, 3, 6
Measured: 6 months
Defecation questionnaire
follow up the patients at Month 0, 3, 6
Measured: 6 months
Gastrointestinal Symptoms
follow up the patients at Month 0, 3, 6
Measured: 6 months
The Kidney Disease Quality of Life
follow up the patients at Month 0, 3, 6
Measured: 6 months
The Occurrence of Cardiovascular Event
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionFeb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Agricultural University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Aerospace Center Hospital, General Hospital of Chinese Armed Police Forces, Beijing Anzhen Hospital, Beijing Biostats Technology Co. Ltd., Beijing Heyiyuan Biotech Co. Ltd.
- Responsible party
- Principal investigator, Fazheng Ren, China Agricultural University
- Investigators
- Fazheng Ren, PhD, Principal investigator, China Agricultural Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010735
- Sponsor's protocol ID
- CAUPCKD-02
- Status last verified
- Oct 2020
- First submitted
- 28 Dec 2016
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vaziri ND, Wong J, Pahl M, Piceno YM, Yuan J, DeSantis TZ, Ni Z, Nguyen TH, Andersen GL. Chronic kidney disease alters intestinal microbial flora. Kidney Int. 2013 Feb;83(2):308-15. doi: 10.1038/ki.2012.345. Epub 2012 Sep 19.
PubMed 22992469Poesen R, Windey K, Neven E, Kuypers D, De Preter V, Augustijns P, D'Haese P, Evenepoel P, Verbeke K, Meijers B. The Influence of CKD on Colonic Microbial Metabolism. J Am Soc Nephrol. 2016 May;27(5):1389-99. doi: 10.1681/ASN.2015030279. Epub 2015 Sep 23.
PubMed 26400570Koppe L, Mafra D, Fouque D. Probiotics and chronic kidney disease. Kidney Int. 2015 Nov;88(5):958-66. doi: 10.1038/ki.2015.255. Epub 2015 Sep 16.
PubMed 26376131Anders HJ, Andersen K, Stecher B. The intestinal microbiota, a leaky gut, and abnormal immunity in kidney disease. Kidney Int. 2013 Jun;83(6):1010-6. doi: 10.1038/ki.2012.440. Epub 2013 Jan 16.
PubMed 23325079Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol. 2014 Apr;25(4):657-70. doi: 10.1681/ASN.2013080905. Epub 2013 Nov 14.
PubMed 24231662Poesen R, Claes K, Evenepoel P, de Loor H, Augustijns P, Kuypers D, Meijers B. Microbiota-Derived Phenylacetylglutamine Associates with Overall Mortality and Cardiovascular Disease in Patients with CKD. J Am Soc Nephrol. 2016 Nov;27(11):3479-3487. doi: 10.1681/ASN.2015121302. Epub 2016 May 26.
PubMed 27230658Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.
PubMed 17898101Aronov PA, Luo FJ, Plummer NS, Quan Z, Holmes S, Hostetter TH, Meyer TW. Colonic contribution to uremic solutes. J Am Soc Nephrol. 2011 Sep;22(9):1769-76. doi: 10.1681/ASN.2010121220. Epub 2011 Jul 22.
PubMed 21784895
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics on Metabolism of Uremic Toxin in Patients With End Stage Renal Disease (ESRD)
- ClinicalTrials.gov ID
- NCT03010735
- Acronym / sponsor ID
- CAUPCKD-02
- Conditions
- Kidney Failure, Chronic
- Keywords
- Kidney Failure, Chronic, Probiotics, Uremic toxins, Gastrointestinal Microbiome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- China Agricultural UniversityUniversity, hospital or other
- Collaborators
- Peking University Aerospace Center Hospital, General Hospital of Chinese Armed Police Forces, Beijing Anzhen Hospital, Beijing Biostats Technology Co. Ltd., Beijing Heyiyuan Biotech Co. Ltd.
- Study start
- Jun 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Jan 2017 (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 purpose of this study is to investigate the effects of oral administration of probiotics on the metabolism of uremic toxins, in the patients with End Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: probioticsThe patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe patient take two placebo chewing tablet per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years old
- Patients who diagnosed as ESRD with hemodialysis
- Fixed hemodialysis cycle (average 3 times a week)
- Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.)
- Agree to sign the informed consent form
Key exclusion criteria (4 listed)
- Taking antibiotics or antifungal drugs within 30 days before the study
- Have serious allergic reaction to skim milk powder
- Researcher are not sure whether the subjects are willing or able to complete the study
- Subject participated in other research projects within two months before the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probioticsDaily take 4.0E+10 CFU of probiotics | Dietary supplement | Probiotics |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Changes in Microbiota-derived uremic toxin
Time frame: 6 months
follow up the patients at Month 0, 3, 6
7 secondary outcomes
Changes in Fecal Microbiome
Time frame: 6 months
Changes in Fecal metabolites
Time frame: 6 months
Changes in Blood metabolites
Time frame: 6 months
Defecation questionnaire
Time frame: 6 months
Gastrointestinal Symptoms
Time frame: 6 months
The Kidney Disease Quality of Life
Time frame: 6 months
The Occurrence of Cardiovascular Event
Time frame: 6 month follow-up
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 22 Oct 2020.
- Background: PubMed 22992469Vaziri ND, Wong J, Pahl M, Piceno YM, Yuan J, DeSantis TZ, Ni Z, Nguyen TH, Andersen GL. Chronic kidney disease alters intestinal microbial flora. Kidney Int. 2013 Feb;83(2):308-15. doi: 10.1038/ki.2012.345. Epub 2012 Sep 19.
- Background: PubMed 26400570Poesen R, Windey K, Neven E, Kuypers D, De Preter V, Augustijns P, D'Haese P, Evenepoel P, Verbeke K, Meijers B. The Influence of CKD on Colonic Microbial Metabolism. J Am Soc Nephrol. 2016 May;27(5):1389-99. doi: 10.1681/ASN.2015030279. Epub 2015 Sep 23.
- Background: PubMed 26376131Koppe L, Mafra D, Fouque D. Probiotics and chronic kidney disease. Kidney Int. 2015 Nov;88(5):958-66. doi: 10.1038/ki.2015.255. Epub 2015 Sep 16.
- Background: PubMed 23325079Anders HJ, Andersen K, Stecher B. The intestinal microbiota, a leaky gut, and abnormal immunity in kidney disease. Kidney Int. 2013 Jun;83(6):1010-6. doi: 10.1038/ki.2012.440. Epub 2013 Jan 16.
- Background: PubMed 24231662Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol. 2014 Apr;25(4):657-70. doi: 10.1681/ASN.2013080905. Epub 2013 Nov 14.
- Background: PubMed 27230658Poesen R, Claes K, Evenepoel P, de Loor H, Augustijns P, Kuypers D, Meijers B. Microbiota-Derived Phenylacetylglutamine Associates with Overall Mortality and Cardiovascular Disease in Patients with CKD. J Am Soc Nephrol. 2016 Nov;27(11):3479-3487. doi: 10.1681/ASN.2015121302. Epub 2016 May 26.
- Background: PubMed 17898101Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.
- Background: PubMed 21784895Aronov PA, Luo FJ, Plummer NS, Quan Z, Holmes S, Hostetter TH, Meyer TW. Colonic contribution to uremic solutes. J Am Soc Nephrol. 2011 Sep;22(9):1769-76. doi: 10.1681/ASN.2010121220. Epub 2011 Jul 22.
- Individual participant dataSharing planned: No
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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.
Fazheng Ren, PhD principal investigator
China Agricultural Universtiy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing probiotics in people with Kidney Failure, Chronic, run by China Agricultural University at 3 sites in China.
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 5 inclusion and 4 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in Microbiota-derived uremic toxin (time frame: 6 months). 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 NCT03010735, which also lists 8 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 22 Oct 2020.