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.
- Conditions
- Recurrent Kidney Stones With Colicky Pain
- Interventions
- Other: MetProrenes
- Registration Number
- NCT06477471
- Lead Sponsor
- NovoBliss Research Pvt Ltd
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 14
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The subject is an adult aged between 18 to 55 years old.
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The subject has a history of recurrent kidney stone colic or acute episode of colicky pain on clinical examination by Physician.
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Subject having refrigerator at their home for storage of test product.
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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.
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The subject is willing to abide by the study protocol and restrictions, including abstaining from using any other oral or topical treatments for kidney stone colic during the study period.
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The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
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If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
- Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
- Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.
- 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.
- The subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders.
- The subject has participated in clinical studies or received any investigational agent in the previous 30 days.
- The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Recurrent Kidney Stone with Colicky Pain MetProrenes Take one slow-release capsule twice a day, after meal, orally.
- Primary Outcome Measures
Name Time Method Change in the colicky pain On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). 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
Changes in Urine Calcium On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the effectiveness of the test treatment in terms of changes in Urine Calcium examined by urinalysis after 24h-urine collection
Changes in Urine Sodium On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the effectiveness of the test treatment in terms of changes in Urine Sodium examined by urinalysis after 24h-urine collection
Changes in Urine R/M On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the effectiveness of the test treatment in terms of changes in Urine R/M examined by urinalysis after 24h-urine collection
Changes in Urine Oxalate On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the effectiveness of the test treatment in terms of changes in Urine Oxalate examined by urinalysis after 24h-urine collection
Changes in Urine pH On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the effectiveness of the test treatment in terms of changes in Urine pH examined by urinalysis after 24h-urine collection
- Secondary Outcome Measures
Name Time Method Changes in Haematocrit On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Haematocrit.
Changes in Differential WBC count On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Differential WBC count.
Changes in Haemoglobin On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Haemoglobin
Changes in Red Blood count On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Red Blood Count.
Changes in red blood cell distribution width On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in red blood cell distribution width
Changes in Total WBC count On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Total WBC count.
Changes in Plateletcrit On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Plateletcrit.
Changes in platelet distribution width On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in platelet distribution width.
Changes in Packed Cell Volume On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Packed cell volume Count.
Changes in Mean corpuscular volume On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Mean corpuscular volume
Changes in Platelet count On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Platelet count.
Changes in Red Blood count morphology On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Red Blood Count morphology.
Changes in mean corpuscular hemoglobin On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in mean corpuscular hemoglobin
Changes in mean corpuscular hemoglobin concentration On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in mean corpuscular hemoglobin concentration
Changes in Serum Glutamic Pyruvic Transaminase On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Serum Glutamic Pyruvic Transaminase
Changes in mean platelet volume On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in mean platelet volume.
Changes in Serum Glutamic-Oxaloacetic Transaminase On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Serum Glutamic-Oxaloacetic Transaminase
Changes inSerum Creatinine On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days). Assessment of the safety of the test treatment in terms of abnormal changes in Serum Creatinine.