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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05516472). StuddyBuddy aggregates publicly available trial information.