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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Changes in Urine Oxalate
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
- •The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
- •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.
排除标准
- •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.
研究组 & 干预措施
Recurrent Kidney Stone with Colicky Pain
Take one slow-release capsule twice a day, after meal, orally.
干预措施: MetProrenes (Other)
结局指标
主要结局
Changes in Urine Oxalate
时间窗: 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
Change in the colicky pain
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 pH
时间窗: 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
次要结局
- Changes in Serum Glutamic Pyruvic Transaminase(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in Haematocrit(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in Differential WBC count(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in Haemoglobin(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in Red Blood count(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- 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(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in Plateletcrit(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in platelet distribution width(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in Packed Cell Volume(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in Mean corpuscular volume(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in Platelet count(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- 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 hemoglobin(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in mean corpuscular hemoglobin concentration(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in mean platelet volume(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes in Serum Glutamic-Oxaloacetic Transaminase(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
- Changes inSerum Creatinine(On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).)
研究者
Dr Nayan Patel
Principal Investigator- Medical Director
NovoBliss Research Pvt Ltd