NCT06477471

A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic. Supplementation in Reducing the Risk of Kidney Stone in Adults With Recurrent Kidney Stone Colic or Acute Episode of Colicky Pain.

A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Reducing the Risk of Kidney Stone in Adults With Recurrent Kidney Stone Colic or Acute Episode of Colicky Pain: An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Reducing the Risk of Kidney Stone in Adults with Recurrent Kidney Stone Colic or Acute Episode of Colicky Pain: An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study. 14 adults, with recurrent kidney stone colic or acute episode of colicky pain will be enrolled to ensure 12 subjects complete the study

Detailed description

Potential subjects will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent. Subjects shall be instructed to visit the facility for the following scheduled visits: * Visit 01 \[Day 01\]: Screening, baseline evaluations, enrolment and test treatment dispensing. * Visit 02 \[Day 14 (± 2 days)\]: Treatment End, Follow-up Evaluations.

Conditions

• Recurrent Kidney Stones With Colicky Pain

Interventions

Type	Name	Description
OTHER	MetProrenes	Take one slow-release capsule twice a day, after meal.

Timeline

• Start date: 2024-07-30
• Primary completion: 2024-08-13
• Completion: 2024-08-13
• First posted: 2024-06-27
• Last updated: 2024-06-27