Fecal Microbiota Transplantation in Kidney Stone Patients

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 60% 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 >225mg/day (hypercalciuric group) and oxalate >40mg/day (hyperoxaluric group). Stool samples will be obtained for metagenomic analyses prior to the intervention. 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. Twenty-four hours later, participants will take either the control capsule or the microbial capsules, 2 capsules daily for 7 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05516472
Study type	Interventional
Source	Intermountain Health Care, Inc.
Contact	Anika Isom
Phone	801-507-9292
Email	anika.isom@imail.org
Status	Not yet recruiting
Phase	Early Phase 1
Start date	April 2024
Completion date	March 2027

View Details

See also
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Completed	`NCT03095885` - A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria	N/A
Completed	`NCT01088555` - Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers	N/A
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Recruiting	`NCT05417568` - Oxalate-Driven Host Responses in Kidney Stone Disease	N/A
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Withdrawn	`NCT01560091` - Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fecal Microbiota Transplantation in Kidney Stone Patients — FMT IND

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms