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.
NCT Number: NCT06477471
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Recurrent Kidney Stones With Colicky Pain
Interventions: OTHER: MetProrenes
Sponsor: NovoBliss Research Pvt Ltd
Collaborators: Meteoric Biopharmaceuticals Pvt. Ltd.
Sex: ALL
Age: ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2024-08-13

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

Primary Outcome Measures: Change in the colicky pain, Evaluate the effect of the test treatment in term of change in the colicky pain determined using the VAS scoring where 0 indicates no pain and 10 indicates severe pain, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Urine Calcium, Assessment of the effectiveness of the test treatment in terms of changes in Urine Calcium examined by urinalysis after 24h-urine collection, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Urine Sodium, Assessment of the effectiveness of the test treatment in terms of changes in Urine Sodium examined by urinalysis after 24h-urine collection, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Urine Oxalate, Assessment of the effectiveness of the test treatment in terms of changes in Urine Oxalate examined by urinalysis after 24h-urine collection, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Urine pH, Assessment of the effectiveness of the test treatment in terms of changes in Urine pH examined by urinalysis after 24h-urine collection, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Urine R/M, Assessment of the effectiveness of the test treatment in terms of changes in Urine R/M examined by urinalysis after 24h-urine collection, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Secondary Outcome Measures: Changes in Haemoglobin, Assessment of the safety of the test treatment in terms of abnormal changes in Haemoglobin, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Haematocrit, Assessment of the safety of the test treatment in terms of abnormal changes in Haematocrit., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Red Blood count, Assessment of the safety of the test treatment in terms of abnormal changes in Red Blood Count., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Packed Cell Volume, Assessment of the safety of the test treatment in terms of abnormal changes in Packed cell volume Count., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Red Blood count morphology, Assessment of the safety of the test treatment in terms of abnormal changes in Red Blood Count morphology., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Mean corpuscular volume, Assessment of the safety of the test treatment in terms of abnormal changes in Mean corpuscular volume, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in mean corpuscular hemoglobin, Assessment of the safety of the test treatment in terms of abnormal changes in mean corpuscular hemoglobin, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in mean corpuscular hemoglobin concentration, Assessment of the safety of the test treatment in terms of abnormal changes in mean corpuscular hemoglobin concentration, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in red blood cell distribution width, Assessment of the safety of the test treatment in terms of abnormal changes in red blood cell distribution width, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Total WBC count, Assessment of the safety of the test treatment in terms of abnormal changes in Total WBC count., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Differential WBC count, Assessment of the safety of the test treatment in terms of abnormal changes in Differential WBC count., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Platelet count, Assessment of the safety of the test treatment in terms of abnormal changes in Platelet count., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in mean platelet volume, Assessment of the safety of the test treatment in terms of abnormal changes in mean platelet volume., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Plateletcrit, Assessment of the safety of the test treatment in terms of abnormal changes in Plateletcrit., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in platelet distribution width, Assessment of the safety of the test treatment in terms of abnormal changes in platelet distribution width., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes inSerum Creatinine, Assessment of the safety of the test treatment in terms of abnormal changes in Serum Creatinine., On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Serum Glutamic Pyruvic Transaminase, Assessment of the safety of the test treatment in terms of abnormal changes in Serum Glutamic Pyruvic Transaminase, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).|Changes in Serum Glutamic-Oxaloacetic Transaminase, Assessment of the safety of the test treatment in terms of abnormal changes in Serum Glutamic-Oxaloacetic Transaminase, On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).