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Recruiting
NCT05516472
Fecal Microbiota Transplantation in Kidney Stone Patients
Conditions: Kidney Stones, Urinary Stone Disease / Nephrolithiasis, Recurrent Calcium-oxalate Kidney Stones
Sex: All
Ages: 18 Years – 69 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 20
Sponsor: Joshua Stern
Location: Park City Hospital Park City Utah
Summary
This open-label pilot study evaluates whether oral microbial transplant therapy can change urine factors associated with recurrent calcium-oxalate kidney stones. Adults with high urine calcium or high urine oxalate will receive antibiotic pretreatment followed by microbial capsules. Changes in 24-hour urine calcium and oxalate and treatment safety will be assessed.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older and younger than 70 years.
* Recent urinary stone disease with at least 50% calcium-oxalate composition confirmed by stone analysis.
* 24-hour urinary calcium \>225 mg/day or urinary oxalate \>40 mg/day.
* Able to provide informed consent.
* Willing to complete safety follow-up, study visits, 24-hour urine collections, and serial stool collections.
* Not actively participating in another interventional urinary stone disease trial.
* eGFR \>=60.
Exclusion Criteria:
* Three or more NIH-defined metabolic syndrome features.
* Any autoimmune disease or inflammatory bowel disease.
* Major gastrointestinal surgery within 3 months, excluding appendectomy or cholecystectomy; history of total colectomy or bariatric surgery.
* Primary or secondary hyperparathyroidism or PTH outside 15-65 pg/mL.
* Pancreatic enzyme replacement, ongoing dialysis, or eGFR \=2 dysphagia.
* Active gastrointestinal infection, toxic megacolon, or small bowel ileus.
* Life expectancy \=80 mg/day.
Source: ClinicalTrials.gov (NCT05516472). StuddyBuddy aggregates publicly available trial information.