NCT05516472

Fecal Microbiota Transplantation in Kidney Stone Patients

Fecal Microbiota Transplantation (FMT CAPSULE DE, FMPCapDE, MTP-CP101) in Kidney Stone Patients (FMT IND STUDY)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Joshua Stern · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure the impact of Microbial Transplant Therapy (MTT) on 24-hour urine parameters in recurrent hypercalciuric and hyperoxaluric kidney stone formers.

Detailed description

In this study, urinary stone disease patients will be recruited from the Park City Urology Clinic at Intermountain Healthcare. Subjects will undergo screening and baseline assessments, including a history and physical exam. A 24-hour urine sample will be collected. Urinary parameters include analysis for calcium, oxalate, uric acid, citrate, NH4, sulfate, pH, Cr, phosphate, sodium, potassium, magnesium, super saturation (SS) CaOx, SSUA, SSCaP, UUN. Microbial Transplant Therapy (MTT), the intervention, will be offered to individuals who produce greater than or equal to 50% calcium-oxalate stones. Pathology reports in the patient's medical record will be used to confirm the stone composition. The cohort of 36 total enrollees will be comprised of four separate study groups. The first group of 12 will include hyperoxaluric patients, the second group of 12 will include hypercalciuric patients, the third group will enroll six patients with hyperoxaluria as a control group, and the fourth group will enroll six patients with hypercalciuria as a control group. Grouping will be determined by 24-hour urine analysis which show measurements of urinary calcium greater than 225mg/day (hypercalciuric group) and oxalate greater than 40mg/day (hyperoxaluric group). Stool samples will be obtained for metagenomic analyses prior to the intervention. The study will begin with a run- in of 7 - 10 treatment patients, which will be followed by the randomization period. In the randomization period, subjects will be assigned to the hypercalciuric and hyperoxaluric arms based upon urine parameters or placed in the control arm by random assignment. Because antibiotic treatment is common during surgery for stones, participants will be treated with 3 days of vancomycin 500 mg orally twice a day and neomycin 1,000 mg orally twice a day. This treatment is for all subjects, rather than only for subjects with recent or planned urological intervention; in order for the MTT to take hold, all patients must be treated with antibiotics. Forty-eight to 72 hours later, participants will take either the control capsule or the microbial capsules, 2 capsules daily for 7 days.

Conditions

• Kidney Stones

Interventions

Type	Name	Description
DRUG	Microbial Transplant Therapy	Participants will take microbial capsules, 2 capsules daily for 7 days
DRUG	Placebo	Participants will take placebo capsules

Timeline

• Start date: 2024-10-10
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2022-08-25
• Last updated: 2025-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study