Chronic Kidney DiseaseNCT05359094
Probiotic Supplements in Chronic Kidney Disease
A study testing Probiotics in people with Chronic Kidney Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with Chronic kidney disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2022to 15 Jul 2024
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 20 years old.
- Patients with 2~3a stage chronic kidney disease.
- Those who can cooperate with the research plan for 3 visits and retain samples (blood, urine).
Who cannot join
- Use of other probiotics during the study.
- Those with active infectious diseases in the past month.
- Those who have used antibiotics within the past 1 month or during the study.
- Women who are pregnant or breastfeeding.
- Obstructive nephropathy within the past month.
- Polycystic kidney disease (polycystic kidney disease).
Show all 10Show fewer
- Acute kidney disease within the past 3 months.
- Gastrointestinal bleeding within the past 3 months.
- Malignancy.
- Severe cardiovascular disease (cardiovascular disease) in the past 3 months, such as coronary artery disease (coronary artery disease), myocardial ischemia (myocardial ischemia), NYHA class IV myocardial failure, cerebrovascular disease, or peripheral artery disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease
This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with Chronic kidney disease.
Read the detailed description
Chronic kidney disease (CKD) with gut microbiota was different from a normal person. Some gut microbiota produces short-chain fatty acids or induces functional enzymes beneficial to patients. On the other hand, some gut microbiota may also metabolize amino acids into p-cresol and indole which were leading to the accumulation of urinary toxins and damage to the kidney. This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins, inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with CKD.
- Conditions
- Chronic Kidney Disease
- Being tested
- Placebo, Probiotics
- Keywords
- Probiotics, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo (Microcrystalline α-cellulose) supplement with a Plant-Dominant Low-Protein Diet
ProbioticsDietary supplement
Probiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| Probiotics | Active comparator | Probiotics Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated glomerular filtration rate (eGFR) measurement
The eGFR level is a maker for kidney function
Measured: Baseline to 24 week
Blood Urea Nitrogen (BUN) levels
Blood Urea Nitrogen
Measured: Baseline to 24 week
Electrolytes Analysis
The concentration of electrolytes analysis in the subject's blood samples
Measured: Baseline to 24 week
Secondary outcomes (12)
Uremic toxins assay
The concentration of p-cresol sulfate level, indoxyl sulfates level, and trimethylamine N-oxide level (TMAO) in the subjects' blood samples
Measured: Baseline to 24 week
Sugar test
The concentration of fasting sugar and HbA1C in the subjects' blood samples
Measured: Baseline to 24 week
Nutrition status
The concentration of albumin,TIBC,TFS and uric acid in the subjects' blood samples
Measured: Baseline to 24 week
Inflammation makers
The concentration of inflammation makers in the subjects' blood samples
Measured: Baseline to 24 week
Liver function
The concentration of ALT and AST in the subjects' blood samples
Measured: Baseline to 24 week
Lipid analysis
The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples
Measured: Baseline to 24 week
The quality of life
Health-related quality of life was measured by 5-level EQ-5D questionnaire
Measured: Baseline to 24 week
Complete Blood Count (CBC) Test
The concentration of CBC test in the subject's blood samples
Measured: Baseline to 24 week
Urine Analysis
Urine specimen collection will be evaluate such as urine routine ,bacteria, protein and MCP-1.
Measured: Baseline to 24 week
24-hour Dietary recall
There will be collected by food models or a photography atlas to estimate portion size.
Measured: Baseline to 24 week
Safety and compliance
Gastrointestinal symptoms measured by questionnaire
Measured: Baseline to 24 week
Grip strength levels
Hand grip strength was measured by grip strength device
Measured: Baseline to 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Jun 2022
- Primary completion8 Aug 2023
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Sponsor
- Investigators
- Cheng-Hsu Chen, MDPHD, Principal investigator, Division of Nephrology in Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359094
- Sponsor's protocol ID
- SF22054A
- Status last verified
- Mar 2023
- First submitted
- 27 Apr 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05359094
- Acronym / sponsor ID
- SF22054A
- Conditions
- Chronic Kidney Disease
- Keywords
- Probiotics, Chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 3 May 2022 (actual)
- 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.
This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with Chronic kidney disease.
Detailed description
Chronic kidney disease (CKD) with gut microbiota was different from a normal person. Some gut microbiota produces short-chain fatty acids or induces functional enzymes beneficial to patients. On the other hand, some gut microbiota may also metabolize amino acids into p-cresol and indole which were leading to the accumulation of urinary toxins and damage to the kidney. This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins, inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with CKD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| Probiotics | Active comparator | Dietary Supplement: ProbioticsProbiotics |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 20 years old.
- Patients with 2~3a stage chronic kidney disease.
- Those who can cooperate with the research plan for 3 visits and retain samples (blood, urine).
Key exclusion criteria (10 listed)
- Use of other probiotics during the study.
- Those with active infectious diseases in the past month.
- Those who have used antibiotics within the past 1 month or during the study.
- Women who are pregnant or breastfeeding.
- Obstructive nephropathy within the past month.
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 |
|---|---|---|
| PlaceboPlacebo (Microcrystalline α-cellulose) supplement with a Plant-Dominant Low-Protein Diet | Dietary supplement | Placebo |
| ProbioticsProbiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet | Dietary supplement | Probiotics |
Primary outcome
Estimated glomerular filtration rate (eGFR) measurement
Time frame: Baseline to 24 week
The eGFR level is a maker for kidney function
Blood Urea Nitrogen (BUN) levels
Time frame: Baseline to 24 week
Blood Urea Nitrogen
Electrolytes Analysis
Time frame: Baseline to 24 week
The concentration of electrolytes analysis in the subject's blood samples
12 secondary outcomes
Uremic toxins assay
Time frame: Baseline to 24 week
Sugar test
Time frame: Baseline to 24 week
Nutrition status
Time frame: Baseline to 24 week
Inflammation makers
Time frame: Baseline to 24 week
Liver function
Time frame: Baseline to 24 week
Lipid analysis
Time frame: Baseline to 24 week
The quality of life
Time frame: Baseline to 24 week
Complete Blood Count (CBC) Test
Time frame: Baseline to 24 week
Urine Analysis
Time frame: Baseline to 24 week
24-hour Dietary recall
Time frame: Baseline to 24 week
Safety and compliance
Time frame: Baseline to 24 week
Grip strength levels
Time frame: Baseline to 24 week
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 23 Jul 2024.
Related trials for Chronic Kidney Disease
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
RecruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Recruiting
Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes
Type 2 Diabetes Mellitus, Acute Kidney Injury
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
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.
Cheng-Hsu Chen, MDPHD principal investigator
Division of Nephrology in Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Chronic Kidney Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 10 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
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?
Estimated glomerular filtration rate (eGFR) measurement (time frame: Baseline to 24 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.