Evaluation of the effect of probiotic consumption on acidosis in patients with chronic kidney failure (CKD) with end stage renal disease (ESRD) whom referred to Luqman Hakim Hospital from September 2023 to Mars 2024

Investigating the effect of probiotics on acidosis in patients with chronic kidney failure (CKD) who visited Luqman Hakim Hospital in the second half of 1402.

The upcoming trial will be a phase 2, double-blind study involving 50 individuals with end-stage renal failure. The study population will be separated into intervention and control groups using the sealed envelope approach. The intervention group will be given prebiotic pills, while the control group will be given a placebo, and the arterial blood gases of all patients will be compared three months after the intervention to the baseline level.

The study location is Luqman Hakim Hospital. The study is a double-blind trial, which means that following randomization, each patient is assigned a label that only the study supervisor is aware of. Patients will be tested for arterial blood gases once before and once after receiving the medication or placebo for three months.

Inclusion: Age between 18 and 60 years, confirmed chronic renal failure for at least 3 months, and under the same dialysis machines and similar filters. ; Exclusion: history of kidney transplant, any possible cause other than CKD for creatinine drop, other causes of metabolic acidosis, use of metformin and antihypertensive drugs.

The intervention group participants are requested to take the prebiotic tablets provided to them everyday after lunch for three months. Cap Lactocare 109 CFU (Cap Lactocare) is the medication utilized. The placebo tablets will be administered to the control group at the same dose.

The primary outcome of the study will be arterial blood gases and serum creatinine level and glomerular filtration rate will be the secondary outcomes

Researchers prepare identical envelopes, each containing a piece of paper indicating a treatment group. The envelopes are shuffled randomly, sealed, and sequentially assigned to participants as they enroll in the study. An independent person opens the envelope assigned to each participant, revealing their treatment group. This method ensures that the treatment assignment remains concealed until the moment of assignment, reducing the potential for bias or manipulation by researchers. It enhances the study's integrity and validity by promoting fairness in treatment allocation.

To achieve double blinding in this study, researchers ensure that both participants and investigators are unaware of the treatment assignments. This involves preparing treatments or interventions that look identical. Randomization is performed using a predetermined schedule, and each treatment is assigned a unique code known only to an independent coordinator. The treatments are labeled with these codes, masking their actual identities. Participants are then assigned treatments based on the randomization schedule, without revealing the true nature of the assigned treatment. Throughout the study, both participants and investigators remain blinded to the treatment allocations, reducing the potential for bias and ensuring the integrity of the research findings.

The study protocol, clinical analysis map, informed consent form, clinical study report, codes used in analysis and data dictionary will be published in an article that shows the final results of the work.

The start of the access period immediately after the publication of the results of the article

The data will be available to researchers and industry.

The permission to perform the analysis will be given only for the purpose of performing meta-analysis in the field of systematic review studies.

To receive the data, send a message to the responsible author of the study, Dr. Farzaneh Fatuhi. Access is possible only through email ff.1975@yahoo.com.

Applicants should send the requested texts and the code of ethics of their desired research along with the work resume to the mentioned email.