A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic. Supplementation in Re… (NCT06477471) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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.
14 participantsStarted 2024-07-30
Plain-language 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
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the colicky pain
Timeframe: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
2
Changes in Urine Calcium
Timeframe: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
3
Changes in Urine Sodium
Timeframe: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
4
Changes in Urine Oxalate
Timeframe: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
5
Changes in Urine pH
Timeframe: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
6
Changes in Urine R/M
Timeframe: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
. 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).
Exclusion criteria
. 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.