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J Renal Inj Prev. Inpress.
doi: 10.34172/jrip.2026.38744
  Abstract View: 67

Clinical Trial

Assessing the effect of probiotic consumption on metabolic acidosis in patients with end-stage renal disease; a randomized, double-blind clinical trial

Melika Gholizade 1 ORCID logo, Farzaneh Futuhi 2* ORCID logo, Masood Zangi 3 ORCID logo, Mohammadreza Hajiesmaeili 3 ORCID logo, Mahdi Amirdosara 3 ORCID logo, Zahra Abbasi 4 ORCID logo, Sara Rashki Ghalehnoo 5 ORCID logo, Malihe Abniki 6 ORCID logo, Zahra Sahraei 7* ORCID logo

1 Department of Internal Medicine, School of Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
2 Department of Adult Nephrology, School of Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3 Critical Care Quality Improvement Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4 Hearing Disorders Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
5 Department of Cardiology, School of Medicine, Amir Al Momenin Hospital, Zabol University of Medical Sciences, Zabol, Iran
6 Department of Anesthesiology, Shohada-E-Tajrish Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
7 Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
*Corresponding Authors: Farzaneh Futuhi, Email: ff.1975@yahoo.com; Zahra Sahraei, Email: Zahra.sahraei@yahoo.com

Abstract

Introduction: Patients with end-stage renal disease (ESRD) frequently experience disturbances in acid–base homeostasis, which contribute to adverse clinical outcomes and complicate management. Emerging evidence suggests that modulation of the gut microbiota through probiotic supplementation may influence systemic metabolic and respiratory parameters.

Objectives: This study aimed to evaluate the effect of probiotic supplementation on acid–base homeostasis compared with standard care.

Materials and Methods: This randomized, double‑blind, controlled clinical trial was conducted at Loghman Hakim hospital, Tehran, Iran, between 2023 and 2024. Twenty‑one patients with ESRD and metabolic acidosis were included in the final analysis. Participants were randomized to the intervention group (n = 12) receive daily probiotic supplementation (Cap Lactocare, 10⁹ CFU, once after lunch for three months) plus standard care, or standard care alone (n = 9). Arterial blood gas parameters (ABG), including pH, carbon dioxide (PCO₂), and bicarbonate (HCO₃– ), were measured before and after intervention, and statistical analyses were performed using non‑parametric tests to compare within‑ and between‑group changes.

Results: The final analysis included 12 probiotic and 9 control patients. Before intervention, ABG parameters showed no significant differences in pH, PCO₂), and HCO₃– . After intervention, the probiotic group demonstrated significantly higher pH (7.39 vs. 7.36), lower PCO₂ (39.26 vs. 41.72 mm Hg), and elevated HCO₃– (27.22 vs. 24.51 mmol/L) compared with controls (P < 0.05). Within-group analyses confirmed significant improvements in pH (Δ +1.93%) and HCO₃– (Δ +32.78%) alongside a reduction in PCO₂ (Δ –5.80%) in the probiotic group (P < 0.05), whereas the control group showed increases in pH (Δ +1.37%) and HCO₃– (Δ +16.99%) (P < 0.05), without significant change in PCO₂ (P = 0.931).

Conclusion: Probiotic supplementation in patients with ESRD indicated a more comprehensive modulation of both metabolic and respiratory components of acid–base homeostasis compared with standard care.

Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials with code (IRCT20230608058421N1; https://irct.behdasht.gov.ir/trial/70981), and ethical code from Shahid Beheshti University of Medical Sciences (IR.SBMU.MSP.REC.1402.099).



Implication for health policy/practice/research/medical education:

The results of this clinical trial study indicated that probiotic supplementation in patients with end-stage renal disease (ESRD) led to a more comprehensive improvement in acid–base homeostasis compared with standard care. These findings highlight the potential of probiotics as an effective adjunctive therapy for optimizing both respiratory and metabolic components of acid–base balance in this patient population.

Please cite this paper as: Gholizade M, Futuhi F, Zangi M, Hajiesmaeili M, Amirdosara M, Abbasi Z, Rashki Ghalehnoo S, Abniki M, Sahraei Z. Assessing the effect of probiotic consumption on metabolic acidosis in patients with end-stage renal disease; a randomized, double-blind clinical trial. J Renal Inj Prev. 2026; x(x): e38744. doi: 10.34172/jrip.2026.38744.

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