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IRCT20230608058421N1 IRCT 2023-06-29 Shahid Beheshti University of Medical Sciences The effect of probiotics on patients with end-stage renal failure 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 2023-08-23 anticipated 50 Complete https://irct.ir/trial/70981 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 2 Chronic kidney disease. Intervention 1: Intervention group: Probiotic group, patients in this group will be advised to take probiotic capsules orally every day after lunch for three months. The medicine used will be Cap Lactocare 109 CFU (Cap Lactocare). Intervention 2: Control group: Intervention group: patients in this group will be advised to take placebo capsules orally every day after lunch for three months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the end of the study, it will be published only at the request of the reviewers of the research journals and with the consent of the authors responsible for this publication, otherwise no.
public Farzaneh Futuhi
South Kargar
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 ff.1975@yahoo.com Shahid Beheshti University of Medical Sciences scientific Melika Gholizadeh
South Kargar
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 Melika_g1368@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The age of entering the study is considered between 18 and 60 years. Confirmation of chronic kidney failure from the patient's tests or documents that show a structural or functional disorder, or in other words, albuminuria or creatinine drop. More than three months have passed since the mentioned disorders. Affected patients should be under the same dialysis machines and similar filters. 18 years 60 years Both History of kidney transplant Any possible cause other than CKD for creatinine drop Other causes of metabolic acidosis such as diarrhea, heart failure or shock Metformin use Taking blood pressure lowering medications due to the possibility of acidosis N18 Chronic kidney disease (CKD) Treatment - Drugs Placebo Intervention group: Probiotic group, patients in this group will be advised to take probiotic capsules orally every day after lunch for three months. The medicine used will be Cap Lactocare 109 CFU (Cap Lactocare). Control group: Intervention group: patients in this group will be advised to take placebo capsules orally every day after lunch for three months. Arterial blood pH. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Arterial blood gas measurement will be assessed by the optical method by the Edan device in the laboratory of Luqman Hakim Hospital. Arterial blood HCO3. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Arterial blood gas measurement will be assessed by the optical method by the Edan device in the laboratory of Luqman Hakim Hospital. Serum creatinine level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: It will be assessed by the Pars Azmoon kit in the laboratory of Luqman Hakim Hospital. Glomerular filtration rate. Timepoint: Before intervention and 3 months after intervention. Method of measurement: eGFR (mL/min)= [(140 - age) × Wt / (0.814 × Serum Creatinine level in µmol/L)] × (0.85 if female). Shahid Beheshti University of Medical Sciences Approved 2023-06-03 Ethics committee of Shahid Beheshti University of Medical Sciences Velenjac, Daneshju Blvd, Koodakyar Ave Tehran Tehran Iran (Islamic Republic of)