NIPH Clinical Trials Search

A Placebo-Controlled Trial of LitControl pH Down in Patients with Infection-Related Urolithiasis

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Infectious Urolithiasis
Date of first enrollment	13/02/2026
Target sample size	90
Countries of recruitment
Study type	Interventional
Intervention(s)	Intervention Group: Participants will receive LitControl pH Down 420 mg, administered as two capsules twice daily (after breakfast and dinner) for a duration of 24 weeks. Placebo Group: Participants will receive placebo capsules, administered as two capsules twice daily (after breakfast and dinner) for a duration of 24 weeks.

Outcome(s)

Primary Outcome	Stone-related events during the 6-month (24-week) treatment period, including the development of new stones, growth or increase in existing stones, pain or hematuria, stone-associated urinary tract infections, and therapeutic interventions.
Secondary Outcome	Stone-related events during the 3-month (12-week) treatment period, including the development of new stones, growth or increase in existing stones, pain or hematuria, stone-associated urinary tract infections, and therapeutic interventions. Change in urinary pH from baseline Positive rate of urine cultures Changes in pyuria Inflammatory markers in blood tests

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 90age old
Gender	Both
Include criteria	Patients with infectious urolithiasis following surgical treatment 1.Patients aged 18 and 90 years who were diagnosed with urolithiasis and underwent surgical treatment (extracorporeal shock wave lithotripsy, transurethral lithotripsy, or percutaneous nephrolithotomy) at the participating institution. 2.Patients whose most recent surgical stone analysis at the participating institution confirmed the presence of calcium phosphate and/or magnesium ammonium phosphate in the stone composition. 3.Patients who have provided written informed consent to participate in the study.
Exclude criteria	Patients who are unable to take oral medication or are unlikely to benefit from the investigational drug due to severe gastrointestinal malabsorption. Women who are pregnant, breastfeeding, or may be pregnant. Patients with active urinary tract infections accompanied by fever 38 degrees. Patients receiving best supportive care (BSC) due to terminal cancer or equivalent conditions. Any other patients deemed inappropriate for study participation by the principal or sub-investigator.