Chronic Kidney Disease (Stages 3b-5)MICKIDNCT07260682
Effect of Probiotic Supplementation on Renal Function, Vascular Calcification and Alterations in Bone Mineral Metabolism in Patients With Chronic Kidney Disease
A study testing Probiotic in people with Chronic Kidney Disease (Stages 3b-5), run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
INTRODUCTION You have been asked to participate in a research study of patients with chronic kidney disease to assess whether a probiotic supplement (a commercially available product that is not a medication) can help slow the progression of your vascular calcification and thus improve your health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stages 3b-5)
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 12 Apr 2021to 10 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be of legal age (≥18 years).
- Patients with stage 5 CKD in pre-dialysis or dialysis with evidence of cardiovascular disease. Calcification will be quantified using the Kaupilla and Adragao indices as indicated in Appendix 1. All radiographs necessary to assess the degree of calcification (both at the beginning and end of the study) will be examined by the same radiologist. To avoid bias in the assessments, the calculation of the Adragao and Kaupilla indices will be performed by staff from the Radiology Department of the Reina Sofía University Hospital.
- Negative pregnancy test.
- Patient capable of understanding the study procedures and who provides informed consent to participate in the research project.
Who cannot join
- 1 Patients diagnosed with or suspected of having inflammatory bowel disease.
- 2. Patients undergoing antibiotic treatment within the last two months prior to the start of the study.
- 3. Patients with recurrent infections or diverticula treated intermittently with antibiotics.
- 4. No cardiovascular history.
- 5. Other cardiovascular or metabolic disorders.
- 6. Pregnant or breastfeeding women, or women planning to become pregnant.
Show all 9Show fewer
- 7. Drug or alcohol addiction that, in the investigator's opinion, could interfere with compliance with the study requirements.
- 8. Participation in other clinical studies.
- 9. Incapacity or unwillingness of the individual, legal guardian, or representative to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
INTRODUCTION You have been asked to participate in a research study of patients with chronic kidney disease to assess whether a probiotic supplement (a commercially available product that is not a medication) can help slow the progression of your vascular calcification and thus improve your health. Your participation in this study does not replace your usual medical care.
Why is this study being conducted? The purpose of this study is to demonstrate that a probiotic supplement is helpful in slowing the progression of your vascular calcification. We also intend to assess whether changes in vascular calcification are associated with changes in mineral metabolism parameters, inflammation, and kidney function.
Read more
What does the study involve? This study will include patients with chronic kidney disease and vascular calcification.
Half of the patients will receive the probiotic supplement Probimel at a dose of 15 ml per day. The study will last 6 months, during which time your kidney function, vascular calcification, and parameters related to uremic toxins, inflammation, and mineral metabolism will be evaluated. The study physician may adjust the dosage of your usual medication before you begin using the study food product, or during the study if your symptoms change. Please ask your study physician or team any questions you may have.
STUDY PROCEDURES If you agree to participate in this study and sign this Consent Form, you will undergo some tests during a screening period to determine if you are eligible to participate. This screening takes place before your inclusion in the main phase of the study.
At each study visit, you will be asked about:
- any medications you are currently taking or any changes to them,
- any problems you are experiencing,
- any side effects you may be having, which may or may not be related to the study,
- whether you have visited any other doctors or hospitals.
Following the explanation of the research project and the signing of informed consent during the initial screening visit, the patient's medical history will be reviewed, anthropometric measurements will be taken, and existing biochemical data will be analyzed.
During the first visit, blood will be drawn, stool samples will be collected, and the degree of vascular calcification will be assessed using abdominal, pelvic, and hand X-rays. The study and treatment with the probiotic supplement will begin at this point.
Subsequent visits will be scheduled at 2 and 6 months, during which blood samples (hematology and biochemistry) will be taken. Additionally, at the final visit (month 6), stool collection and X-rays will be repeated.
At this point, treatment will be discontinued, and the study will be concluded, with a final follow-up visit scheduled to ensure that all studied parameters are stable and within the normal range. Excess blood samples from this study will be stored in the Biobank of the Reina Sofía University Hospital in Córdoba and may be used later in other scientific studies. For this reason, you will receive an additional document in which you give your consent for the proper storage of the samples in the biobank.
What should I do during the study?
To obtain reliable information from this study on the effect of probiotic supplementation in patients with chronic kidney disease and vascular calcification, you are expected to do the following:
- Follow your study physician's instructions.
- Attend all scheduled study visits and complete all procedures.
- Review all medications you are taking with your study physician. Certain medications you are currently taking or have taken in the past may prevent you from participating in this study.
- Some procedures/illnesses you have had in the past may prevent you from participating in this study. • Take and store your study medication as directed, and return any leftover medication and/or empty containers to your doctor at each visit.
- Do not share your study medication with anyone. You are the only person authorized to take it.
- Keep your study medication and materials out of the reach and sight of children and anyone who cannot read or understand all the information about it.
- Tell the study staff about any health problems you have, even if you think they are not important.
- Tell the study staff if you wish to stop participating in this study.
- Do not participate in any other research studies.
- Conditions
- Chronic Kidney Disease (Stages 3b-5)
- Being tested
- Probiotic
- 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.
ProbioticDietary supplement
Supplement: Lactobacillus DMG0017 Probimel Dosage: 15 ml/day for 6 months. Directions: Take alone or diluted in juice, any sugary drink, or yogurt. Pharmaceutical Form: Lactobacillus oral solution Route of administration: oral
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze the effect of probiotic supplementation
To analyze the effect of probiotic supplementation on the progression of vascular calcification during chronic kidney disease
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start12 Apr 2021
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stages 3b-5)Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260682
- Sponsor's protocol ID
- PI20/0660
- Other IDs
- PI20/0660
- Acronym
- MICKID
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplementation on Renal Function, Vascular Calcification and Alterations in Bone Mineral Metabolism in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07260682
- Acronym / sponsor ID
- MICKID / PI20/0660
- Conditions
- Chronic Kidney Disease (Stages 3b-5)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 3 Dec 2025 (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.
INTRODUCTION You have been asked to participate in a research study of patients with chronic kidney disease to assess whether a probiotic supplement (a commercially available product that is not a medication) can help slow the progression of your vascular calcification and thus improve your health. Your participation in this study does not replace your usual medical care.
Why is this study being conducted? The purpose of this study is to demonstrate that a probiotic supplement is helpful in slowing the progression of your vascular calcification. We also intend to assess whether changes in vascular calcification are associated with changes in mineral metabolism parameters, inflammation, and kidney function.
What does the study involve? This study will include patients with chronic kidney disease and vascular calcification.
Half of the patients will receive the probiotic supplement Probimel at a dose of 15 ml per day. The study will last 6 months, during which time your kidney function, vascular calcification, and parameters related to uremic toxins, inflammation, and mineral metabolism will be evaluated. The study physician may adjust the dosage of your usual medication before you begin using the study food product, or during the study if your symptoms change. Please ask your study physician or team any questions you may have.
STUDY PROCEDURES If you agree to participate in this study and sign this Consent Form, you will undergo some tests during a screening period to determine if you are eligible to participate. This screening takes place before your inclusion in the main phase of the study.
At each study visit, you will be asked about:
- any medications you are currently taking or any changes to them,
- any problems you are experiencing,
- any side effects you may be having, which may or may not be related to the study,
- whether you have visited any other doctors or hospitals.
Following the explanation of the research project and the signing of informed consent during the initial screening visit, the patient's medical history will be reviewed, anthropometric measurements will be taken, and existing biochemical data will be analyzed.
During the first visit, blood will be drawn, stool samples will be collected, and the degree of vascular calcification will be assessed using abdominal, pelvic, and hand X-rays. The study and treatment with the probiotic supplement will begin at this point.
Subsequent visits will be scheduled at 2 and 6 months, during which blood samples (hematology and biochemistry) will be taken. Additionally, at the final visit (month 6), stool collection and X-rays will be repeated.
At this point, treatment will be discontinued, and the study will be concluded, with a final follow-up visit scheduled to ensure that all studied parameters are stable and within the normal range. Excess blood samples from this study will be stored in the Biobank of the Reina Sofía University Hospital in Córdoba and may be used later in other scientific studies. For this reason, you will receive an additional document in which you give your consent for the proper storage of the samples in the biobank.
What should I do during the study?
To obtain reliable information from this study on the effect of probiotic supplementation in patients with chronic kidney disease and vascular calcification, you are expected to do the following:
- Follow your study physician's instructions.
- Attend all scheduled study visits and complete all procedures.
- Review all medications you are taking with your study physician. Certain medications you are currently taking or have taken in the past may prevent you from participating in this study.
- Some procedures/illnesses you have had in the past may prevent you from participating in this study. • Take and store your study medication as directed, and return any leftover medication and/or empty containers to your doctor at each visit.
- Do not share your study medication with anyone. You are the only person authorized to take it.
- Keep your study medication and materials out of the reach and sight of children and anyone who cannot read or understand all the information about it.
- Tell the study staff about any health problems you have, even if you think they are not important.
- Tell the study staff if you wish to stop participating in this study.
- Do not participate in any other research studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be of legal age (≥18 years).
- Patients with stage 5 CKD in pre-dialysis or dialysis with evidence of cardiovascular disease. Calcification will be quantified using the Kaupilla and Adragao indices as indicated in Appendix 1. All radiographs necessary to assess the degree of calcification (both at the beginning and end of the study) will be examined by the same radiologist. To avoid bias in the assessments, the calculation of the Adragao and Kaupilla indices will be performed by staff from the Radiology Department of the Reina Sofía University Hospital.
- Negative pregnancy test.
- Patient capable of understanding the study procedures and who provides informed consent to participate in the research project.
Key exclusion criteria (9 listed)
- 1 Patients diagnosed with or suspected of having inflammatory bowel disease.
- 2. Patients undergoing antibiotic treatment within the last two months prior to the start of the study.
- 3. Patients with recurrent infections or diverticula treated intermittently with antibiotics.
- 4. No cardiovascular history.
- 5. Other cardiovascular or metabolic disorders.
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 |
|---|---|---|
| ProbioticSupplement: Lactobacillus DMG0017 Probimel Dosage: 15 ml/day for 6 months. Directions: Take alone or diluted in juice, any sugary drink, or yogurt. Pharmaceutical Form: Lactobacillus oral solution Route of administration: oral | Dietary supplement | – |
Primary outcome
To analyze the effect of probiotic supplementation
Time frame: 6 months
To analyze the effect of probiotic supplementation on the progression of vascular calcification during chronic kidney disease
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 3 Dec 2025.
Related trials for Chronic Kidney Disease (Stages 3b-5)
Not yet recruitingObservational study
Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot Study
Dialysis, Chronic Kidney Disease (Stages 3b-5)
Not yet recruiting
Pistachio Consumption in Patients With Chronic Kidney Disease
Chronic Kidney Disease (Stages 3b-5)
RecruitingObservational study
Fostering Self-Empowerment in CKD Patients Through Food Choice Mapping
CKD, Chronic Kidney Disease (Stages 3b-5)
Active, not recruiting
Strategies to Transform Kidney Care and Improve Pursuit of Transplant
Kidney Disease, Kidney Transplant
Not yet recruiting
Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis
Chronic Kidney Disease (Stages 3b-5), Anemia Associated With Chronic Kidney 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Chronic Kidney Disease (Stages 3b-5), run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 4 inclusion and 9 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 3 Dec 2025. 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 Spain. 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?
To analyze the effect of probiotic supplementation (time frame: 6 months). 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 3 Dec 2025.