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Fecal Microbiota Transplantation in Kidney Stone Patients
Fecal Microbiota Transplantation (FMT CAPSULE DE, FMPCapDE, MTP-CP101) in Kidney Stone Patients (FMT IND STUDY)
Who can join
Ages 18 to 69 · All sexes
Full eligibility criteria
Inclusion Criteria: * Age 18 years or older and younger than 70 years. * Recent urinary stone disease with at least 50% calcium-oxalate composition confirmed by stone analysis. * 24-hour urinary calcium \>225 mg/day or urinary oxalate \>40 mg/day. * Able to provide informed consent. * Willing to complete safety follow-up, study visits, 24-hour urine collections, and serial stool collections. * Not actively participating in another interventional urinary stone disease trial. * eGFR \>=60. Exclusion Criteria: * Three or more NIH-defined metabolic syndrome features. * Any autoimmune disease or inflammatory bowel disease. * Major gastrointestinal surgery within 3 months, excluding appendectomy or cholecystectomy; history of total colectomy or bariatric surgery. * Primary or secondary hyperparathyroidism or PTH outside 15-65 pg/mL. * Pancreatic enzyme replacement, ongoing dialysis, or eGFR \<60. * Chemotherapy in the prior year or concurrent intensive cancer therapy. * Antibiotics within 3 months of study entry, continued antibiotic need, or anticipated antibiotic use in the next 4 weeks. * Unable to complete required washout from potassium citrate, thiazides, or proton pump inhibitors. * Pregnant, breastfeeding, or planning pregnancy during the study. * Unable or unwilling to swallow capsules, including CTCAE grade \>=2 dysphagia. * Active gastrointestinal infection, toxic megacolon, or small bowel ileus. * Life expectancy \<6 months. * Prior FMT or microbiome-based product outside this study. * Severe anaphylactic or anaphylactoid food allergy. * Solid organ transplant recipient. * Any condition jeopardizing safety or rights, preventing completion, or confounding results. * Urinary oxalate \>=80 mg/day.
About the study
This open-label pilot study evaluates whether oral microbial transplant therapy can change urine factors associated with recurrent calcium-oxalate kidney stones. Adults with high urine calcium or high urine oxalate will receive antibiotic pretreatment followed by microbial capsules. Changes in 24-hour urine calcium and oxalate and treatment safety will be assessed.
What is being tested
- Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101) (drug)
- Vancomycin and neomycin antibiotic pretreatment (drug)
Sponsor: Joshua Stern · Participants: 20 · Started: Oct 10, 2024
Contact the study team
- Nic Unsworth · Phone: (801) 507-8280
- Joshua Stern, MD · Phone: (435) 658-7400
Official record on ClinicalTrials.gov — NCT05516472
Locations in the U.S.
| Utah | Park City Hospital, Park City |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.