Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT05081960
Eligibility Criteria:
Inclusion Criteria:
* Male/Female, 18 - 65 years old
* No self-reported kidney stones during their lifetime (controls)
* Ultrasound examination confirming absence of kidney stones (controls)
* Have had at least 1 incidence of a clinically confirmed calcium-based kidney stone in the last 12 months (stone formers)
* Ability to collect a clean catch urine sample
* Prescription and over-the-counter drugs unchanged for ≥30 days
* Willingness to provide medical information, blood, urine, and fecal samples
Exclusion Criteria:
* Current, or within 30 days, use of antibiotics or antifungals
* Current, or within 30 days, use of vitamin K antagonists
* Current probiotic use or any use within 14 days of screening sample collection should be recorded
* A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy 2021-06-29 1.0 Page 4 of 6
* Fecal incontinence
* History of disorder with abnormal calcium regulation such as hyperparathyroidism, active malignancy, or osteoporosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05081960
Study Brief:
Protocol Section:
NCT05081960