Fecal Microbiota Transplantation (FMT CAPSULE DE, FMPCapDE, MTP-CP101) in Kidney Stone Patients (FMT IND STUDY)
Joshua Stern
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.
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 sto…
Eligibility
- Age range
- 18–69 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Women and men age greater than or equal to 18 and less than 70 * Recent medical history of USD with greater than or equal to 50% calcium-oxalate stones. All patients will have urinary stone disease confirmed by stone analysis. The study will include patients with either stones extracted by urological intervention or spontaneously passed and collected stones. * 24-hour urinary calcium concentration greater than 225 mg/day or urinary oxalate greater than 40 mg/day * Able to give informed consent. * Willing to undergo telephone follow-up to assess for safety and adverse eve…
Interventions
- DrugMicrobial Transplant Therapy
Participants will take microbial capsules, 2 capsules daily for 7 days
- DrugPlacebo
Participants will take placebo capsules
Location
- Park City HospitalPark City, Utah