Recurrent Kidney Stones With Colicky Pain
Conditions
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.
Interventions
OTHERMetProrenes
Take one slow-release capsule twice a day, after meal.
Sponsors
NovoBliss Research Pvt Ltd
Meteoric Biopharmaceuticals Pvt. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject is an adult aged between 18 to 55 years old. 2. The subject has a history of recurrent kidney stone colic or acute episode of colicky pain on clinical examination by Physician. 3. Subject having refrigerator at their home for storage of test product. 4. 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. 5. 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. 6. The subject is in a stable medical condition, not requiring immediate intervention or hospitalization. 7. If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation. 1. 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). 2. 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.
Exclusion criteria
1. The subject has a history of severe renal impairment or chronic kidney disease. 2. The subject is pregnant/lactating, or is planning on become pregnant during the course of the study. 3. The subject has presence of significant medical or psychiatric conditions that may interfere with study participation or interpretation of results. 4. The subject has a history of substance abuse or dependence. 5. The subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders. 6. The subject has participated in clinical studies or received any investigational agent in the previous 30 days. 7. The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 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 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 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 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 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. |
| 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 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 |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORDr. Nayan K Patel
NovoBliss Research Pvt Ltd
Outcome results
None listed