Mubarak AS, Elshazly A, Mokhtar A, Gadelkareem RA, Azoz NM. Lactulose vs Lactobacillus acidophilus for patients with chronic kidney disease: A randomized controlled trial. World J Nephrol 2026; 15(3): 120870 [DOI: 10.5527/wjn.120870]
Corresponding Author of This Article
Rabea A Gadelkareem, MD, Department of Urology, Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Elgamaa Street, Assiut 71515, Egypt. rabeagad@aun.edu.eg
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Mubarak AS, Elshazly A, Mokhtar A, Gadelkareem RA, Azoz NM. Lactulose vs Lactobacillus acidophilus for patients with chronic kidney disease: A randomized controlled trial. World J Nephrol 2026; 15(3): 120870 [DOI: 10.5527/wjn.120870]
World J Nephrol. Sep 25, 2026; 15(3): 120870 Published online Sep 25, 2026. doi: 10.5527/wjn.120870
Lactulose vs Lactobacillus acidophilus for patients with chronic kidney disease: A randomized controlled trial
Alshaimaa S Mubarak, Ashraf Elshazly, Abdelrahman Mokhtar, Rabea A Gadelkareem, Nashwa M Azoz
Alshaimaa S Mubarak, Ashraf Elshazly, Abdelrahman Mokhtar, Nashwa M Azoz, Department of Internal Medicine-Nephrology Division, Assiut University Hospital, Faculty of Medicine, Assiut University, Assiut 71711, Egypt
Rabea A Gadelkareem, Department of Urology, Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut 71515, Egypt
Author contributions: Gadelkareem RA and Mokhtar A designed the research, collected the data, and wrote the paper; Azoz NM and Mubarak AS contributed to the statistical analysis; Azoz NM, Elshazly A, and Mubarak AS contributed to literature review, writing, and revision; Elshazly A contributed to the supervision of the work. All authors approved the paper.
AI contribution statement: Portions of this manuscript were edited using AI tools (Grammarly and QuillBot Online) for language refinement only. The authors carefully reviewed and verified all AI-assisted outputs and take full responsibility for the scientific content of the manuscript.
Institutional review board statement: This study was approved by the Ethics Committee of the Faculty of Medicine, Assiut University, Egypt, on July 10, 2023.
Clinical trial registration statement: This study was registered on clinicaltrials.gov with the number NCT05934552.
Informed consent statement: All study participants provided informed written consent before participation in the study and enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Corresponding author: Rabea A Gadelkareem, MD, Department of Urology, Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Elgamaa Street, Assiut 71515, Egypt. rabeagad@aun.edu.eg
Received: March 10, 2026 Revised: May 31, 2026 Accepted: June 29, 2026 Published online: September 25, 2026 Processing time: 156 Days and 1.9 Hours
Abstract
BACKGROUND
Chronic kidney disease (CKD) is associated with progressive accumulation of uremic toxins and chronic systemic inflammation. CKD management focuses on treating the underlying disease, controlling risk factors, slowing disease progression, and initiating renal replacement therapy in stage 5. Early CKD is often asymptomatic or presents with mild symptoms such as fatigue and nocturia, whereas symptoms become progressively more severe after stage 3 and worsen further with renal failure. Modulation of the gut microbiota using prebiotics or probiotics has emerged as a promising adjunctive therapeutic strategy. Lactulose, a non-absorbable disaccharide, and Lactobacillus acidophilus (LA), a probiotic, are commonly used to target gut-derived uremic toxins.
AIM
To compare the effects of lactulose and LA on renal functions, inflammatory markers, and gastrointestinal symptoms in patients with non-dialysis CKD.
METHODS
This prospective comparative study was done on a total of 150 patients with non-dialysis CKD stage 3-5 who were randomly subdivided into three groups: The lactulose group included 50 patients with non-dialysis CKD stage 3-5 who received lactulose 30 mL per day divided into 3 doses; the LA group included 50 patients with non-dialysis CKD stage 3-5 who received one tablet of LA twice daily; and group C included 50 patients with non-dialysis CKD stage 3-5 who didn’t receive lactulose or LA. Baseline clinical and laboratory parameters were recorded. Renal function tests (serum creatinine and blood urea), inflammatory markers, and gastrointestinal symptoms were assessed before and after the intervention period.
RESULTS
A total of 150 patients with non-dialysis CKD stages 3-5 were enrolled and equally randomized into three groups: Lactulose (n = 50), LA (n = 50), and control (n = 50). The three groups were comparable in terms of age, sex distribution, body mass index, smoking status, comorbidities, and CKD stage at baseline. Baseline laboratory parameters showed no significant differences among the groups. At the end of the 3-month follow-up period, the LA group achieved the greatest improvement in renal function parameters, as reflected by significantly larger reductions in delta levels of blood urea and serum creatinine compared with both the lactulose and control groups. The mean change in blood urea was -12.45 ± 3.01 mg/dL in the LA group, -5.00 ± 2.45 mg/dL in the lactulose group, and -1.79 ± 3.01 mg/dL in the controls (P = 0.03). Similarly, the mean change in serum creatinine was -20.01% ± 3.45% in the LA group, but -7.33% ± 2.88% in the lactulose group and -6.55% ± 2.44% in the controls (P < 0.001). Improvements in albumin-to-creatinine ratio and estimated glomerular filtration rate were observed in all groups but did not reach statistical significance.
CONCLUSION
Both lactulose and LA demonstrated beneficial effects in non-dialysis CKD patients. However, LA showed superior improvement in uremic parameters and inflammatory status. Gut-directed therapy represents a valuable adjunct in the medical management of CKD.
Core Tip: Modulation of the gut-kidney axis represents a promising adjunctive strategy in the management of chronic kidney disease (CKD). This study highlights that both lactulose and Lactobacillus acidophilus improve uremic parameters and gastrointestinal symptoms in CKD patients; however, Lactobacillus acidophilus demonstrates a more pronounced effect on reducing uremic toxin burden and systemic inflammation. These findings support the clinical relevance of targeting gut dysbiosis to slow disease progression and improve patient outcomes in CKD.
