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.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Meteoric Biopharmaceuticals Pvt. Ltd.
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- 1.Evaluate the effect of the test treatment in term of change in the colicky pain determined using the VAS scoring.
Overview
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. Maximum 12 subjects will be enrolled to complete the study. Duration will be of approximately 14 days which includes 2 visits.
Visit 01 [Day 01]: Screening, baseline evaluations, enrolment and treatment dispensing.
Visit 02 [Day 14]: Treatment End, Final Evaluations.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
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.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.
- •4.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.
- •5.The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
- •a.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).
- •b.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 Subject has a history of severe renal impairment or chronic kidney disease.
- •2 Subject is pregnant/lactating, or is planning on become pregnant during the course of the study.
- •3 Subject has presence of significant medical or psychiatric conditions that may interfere with study participation or interpretation of results.
- •4 Subject has a history of substance abuse or dependence.
- •5 Subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders.
- •6 Subject has participated in clinical studies or received any investigational agent in the previous 30 days.
- •7 Subject has any condition that, in the judgement of investigator, would compromise the safety of subject or study integrity.
Outcomes
Primary Outcomes
1.Evaluate the effect of the test treatment in term of change in the colicky pain determined using the VAS scoring.
Time Frame: 1. Scoring on Day 01 (before administration) for baseline, and post-dosage on Day 14. | 2. On Day 01 (before administration) for baseline, and post-dosage on Day 14.
2.Evaluate the effect of the test treatment in terms of changes in urinalysis parameters such as Urine Calcium, Sodium, Oxalate, pH, and R/M, after 24h-urine collection
Time Frame: 1. Scoring on Day 01 (before administration) for baseline, and post-dosage on Day 14. | 2. On Day 01 (before administration) for baseline, and post-dosage on Day 14.
Secondary Outcomes
- 1.Evaluate the safety of the test treatment in terms of abnormal changes in blood test parameters such as CBC, Serum Creatinine, SGPT, SGOT.(On Day 01 (before administration) for baseline, and post-dosage on Day 14.)
Investigators
Dr Hardik Yadav
NovoBliss Research Private Limited