Fecal Microbiota Transplantation in Kidney Stone Patients

Part of paid clinical trials in Park City, Utah.

Sponsor
Joshua Stern
Study ID
NCT05516472
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Kidney Stones

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Microbial Transplant Therapy — DRUG
    Participants will take microbial capsules, 2 capsules daily for 7 days
  • Placebo — DRUG
    Participants will take placebo capsules

Study Details

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.

Key Dates

Start date
Oct 10, 2024
Status verified
Feb 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Hyperoxaluric group
    Treatment group based on 24 hour urine analysis showing oxalate \>40 mg/day.
  • Experimental: Hypercalciuric Group
    Treatment group based on 24 hour urine analysis showing urinary calcium \>225 mg/day.
  • Placebo Comparator: Control group Hyperoxaluria
    Control group enrolling patients with hyperoxaluria
  • Placebo Comparator: Control group Hypercalciuria
    Control group enrolling patients with hypercalciuria

Primary Outcome Measure

Proportion of participants with an adverse event [ Time Frame: Baseline to day 30 (plus or minus 3 days) after fecal transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Park City HospitalPark CityUtah84060
Joshua Stern, MD
[email protected]
(435) 658-7400
Daniel Del Valle, MS
[email protected]
(801) 507-9421
Joshua Stern, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Park City, UT

By research site
Park City Hospital· Park City, UT

Related Studies