About this trial
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
Eligibility criteria
Qualifiers
The subject is an adult aged between 18 to 55 years old.
The subject has a history of recurrent kidney stone colic or acute episode of colicky pain on clinical examination by Physician.
Subject having refrigerator at their home for storage of test product.
The subject is willing to provide written informed consent and comply with study procedures, including overnight stay for 24 hours at the study centre during both visits.
Disqualifiers
The subject has a history of severe renal impairment or chronic kidney disease.
The subject is pregnant/lactating, or is planning on become pregnant during the course of the study.
The subject has presence of significant medical or psychiatric conditions that may interfere with study participation or interpretation of results.
The subject has a history of substance abuse or dependence.
Trial design
Treatments tested in this trial
- MetProrenes
Treatment groups
Locations
Sponsors and collaborators
NovoBliss Research Pvt Ltd
Lead sponsor
Meteoric Biopharmaceuticals Pvt. Ltd.
Collaborator