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 range18 Years – 55 Years
SexALL
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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.
✓. 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.
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).
. 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.