Effect of Probiotic Supplementation on Renal Function, Vascular Calcification and Alterations in Bone Mineral Metabolism in Patients With Chronic Kidney Disease

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. 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.

Conditions

• Chronic Kidney Disease (Stages 3b-5)

Interventions

DIETARY_SUPPLEMENT

Probiotic

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

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-12

Primary Completion

2023-01-10

Completion

2023-01-10

Countries

• Spain

Study Locations