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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: f
View:

• 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 events

• Willing and able to participate in the study requirements, including study visits, 24-hour urine collection and serial stool collection

• Not actively participating in another interventional USD clinical trial

• Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60.

Locations
United States
Utah
Park City Hospital
RECRUITING
Park City
Contact Information
Primary
Daniel Del Valle, MS
daniel.delvalle@imail.org
(801) 507-9421
Backup
Joshua Stern, MD
joshua.stern@imail.org
(435) 658-7400
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2027-03
Participants
Target number of participants: 36
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Joshua Stern
Collaborators: University of Minnesota

This content was sourced from clinicaltrials.gov