Two-Phase Study Evaluating the Risk Factors for Kidney Stone Disease (KSD) and Effect of Probiotic Use on KSD by Change in Gut Microbiota

Kidney Stone Disease (KSD) imposes a significant societal cost due to its high prevalence and recurrence rates, impacting both patient health and the economy. The most affected age group, 21-40 years, is at its peak productivity. In our institute in Bibinagar, Telangana, we’ve observed a high influx of KSD patients, prompting a study to identify specific risk factors in this area. We wish to conduct this hospital-based study in two phases. The first phase will be a cross-sectional comparative study to identify the risk factors for KSD, including demographic, lifestyle, metabolic, dietary, and environmental factors among the OPD patients presenting to our institute, which is a tertiary care hospital. The gut microbiota will be evaluated in a subset of patients with KSD in comparison to matched controls. The second phase of the study will be an open label RCT with probiotic supplementation in the treatment arm, in addition to the routine standard of care in patients with KSD. A multi-strain probiotic in a dose of 112.5 billion CFU will be given one capsule per day for a total of 8 weeks to the intervention arm along with routine standard of care in the form of dietary counselling. The 24-hour urine parameters and gut microbiota will be rechecked at the end of 12 months along with a repeat USG to see the differences between the two arms and from baseline. In India, no studies have examined probiotic use in KSD. We propose a randomized controlled trial (RCT) to assess the beneficial effect of multi-strain probiotics on KSD patients, potentially offering insights for more effective preventive and therapeutic measures.