Oral Probiotics for Recurrent Kidney Stones in Adults
This study aims to evaluate if taking oral probiotics can reduce pain and alter urine composition in adults with recurrent kidney stones.
MetProrenes
Treatment Study
Summary
Study start date: July 30, 2024
Actual date on which the first participant was enrolled.This study aims to explore the safety and effectiveness of taking oral probiotics as a way to reduce the risk of developing kidney stones in adults who frequently experience kidney stone colic or sudden severe pain due to such stones. The focus is on individuals who have experienced these painful episodes and might benefit from a potential new approach to managing their risk of future stones. This research is significant as it could lead to a simple and accessible method to prevent kidney stones, which are not only painful but can also lead to more serious health issues if left untreated. Participants in the study will first go through a screening process to ensure they meet the specific criteria for inclusion. Once enrolled, they will receive the probiotics treatment to take orally. They need to visit the facility twice during the study. The first visit includes screening and receiving the probiotics, while the second visit occurs approximately two weeks later for follow-up evaluations. The study will assess how well the probiotics work in reducing the likelihood of kidney stone formation and whether the treatment is safe for participants.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.14 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives