Clinical Research Directory

Effect of Synbiotic Therapy on Renal Function Outcomes in Patients With Chronic Kidney Disease Stage III-IV: A Double-blind Randomized Placebo-controlled Trial.

Sponsor: Chittagong Medical College

Summary

Background: Chronic kidney disease (CKD) represents a growing global public health challenge, with rising prevalence in low and middle-income countries, including Bangladesh. Progressive renal dysfunction is frequently accompanied by gut microbiota alterations, leading to increased intestinal permeability and systemic inflammation through the gut-kidney axis. Accumulation of uremic toxins derived from dysbiotic microbiota has been implicated in CKD progression. Synbiotic therapy, combining probiotics and prebiotics, has been proposed as a strategy to restore microbial balance and reduce inflammatory burden. Objective: To evaluate effect of Synbiotic Therapy on Renal Function Outcomes in Patients with Chronic Kidney Disease Stage III-IV. Materials and Methods: This Double-blind, randomized placebo-controlled trial will be conducted in the Department of Nephrology, Chittagong Medical College Hospital, Bangladesh. Approximately 96 adult non-dialysis CKD stage III-IV patients will be enrolled. Participants will be randomly allocated into two arms of treatment. The experimental arm and the control arm. Both arm with receive standard care according to KDIGO recommendations. The experimental arm will receive synbiotic therapy and the control arm with receive placebo in addition to standard therapy. Clinical and laboratory assessments will be performed at baseline, after 1.5 months and after 3 months. Outcome measures are change in S. Creatinine, e-GFR, Blood Urea Nitrogen (BUN), C-Reactive protein (CRP), and Gastrointestinal symptom dynamics using Gastrointestinal System Rating Scale (GSRS). Data Analysis Plan: An intention-to-treat or per protocol approach will be applied as applicable. Parametric or non-parametric tests will be applied as appropriate. Repeated-measures analysis will assess longitudinal changes. Conclusion: The expected findings may clarify the potential role of gut microbiota modulation as an adjunct in CKD management in Bangladesh and similar settings and may inform future multicenter trials.

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