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Fecal Microbiota Transplantation in Kidney Stone Patients

RecruitingEARLY Phase 1Ages 18 Years - 69 YearsAllJoshua Stern
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101)
  • Vancomycin and neomycin antibiotic pretreatment
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Where

1 site
Park City Hospital
Park City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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