Actively Recruiting
Fecal Microbiota Transplantation (FMT CAPSULE DE, FMPCapDE, MTP-CP101) in Kidney Stone Patients (FMT IND STUDY)
Led by Joshua Stern · Updated on 2025-03-10
36
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
J
Joshua Stern
Lead Sponsor
U
University of Minnesota
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Microbial Transplant Therapy (MTT) on 24-hour urine parameters in patients who frequently develop kidney stones composed mainly of calcium oxalate. This early phase 1 study focuses on individuals with recurrent hypercalciuric and hyperoxaluric kidney stones, aiming to understand how MTT impacts urinary components related to stone formation. Participants will be divided into four groups based on their urine calcium and oxalate levels, with some receiving MTT capsules and others receiving placebo capsules. Before treatment, all participants will take antibiotics for three days to prepare for the transplant. Then, participants will take two capsules daily for seven days, either containing the microbial transplant or placebo. Stool samples will be collected before and after the treatment to analyze changes in gut bacteria. Throughout the study, participants will undergo screenings, physical exams, and provide 24-hour urine samples to measure various substances like calcium, oxalate, and uric acid. Researchers will monitor for any adverse events up to 30 days after treatment and assess changes in urine parameters over several weeks. Follow-up includes telephone calls to check safety and ongoing sample collections to understand the treatment's effects on microbiota and stone-related urine measures.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation in Kidney Stone Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and men age greater than or equal to 18 and less than 70
- Recent history of urinary stone disease with at least 50% calcium-oxalate stones confirmed by stone analysis
- 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 participate in telephone follow-up to assess safety and adverse events
- Willing and able to comply with study visits, 24-hour urine collection, and stool sample collection
- Not actively participating in another interventional urinary stone disease clinical trial
- Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60
You will not qualify if you...
- Having three or more features of metabolic syndrome as defined by NIH criteria (large waist, high triglycerides, low HDL cholesterol, high blood pressure, elevated fasting blood sugar)
- Presence of autoimmune features
- Major gastrointestinal surgery within 3 months before enrollment (excluding appendectomy or cholecystectomy)
- Diagnosis of inflammatory bowel disease
- Diagnosis of primary or secondary hyperparathyroidism with PTH outside 15-65 pg/ml range
- Requirement for pancreatic enzyme replacement
- Ongoing dialysis treatment
- Chemotherapy within the last year
- Antibiotic treatment within 3 months before study entry
- Use of potassium citrate, thiazides, or proton pump inhibitors within last 6 months
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Inability or unwillingness to swallow capsules or having significant dysphagia
- Active gastrointestinal infection at enrollment
- Anticipated need for antibiotics in the next 4 weeks
- Known or suspected toxic megacolon or small bowel ileus
- History of total colectomy or bariatric surgery
- Concurrent intensive chemotherapy, radiation, or biological treatment for cancer
- Life expectancy less than 6 months
- Previous fecal microbiota transplant or microbiome-based product use (excluding this study)
- History of severe anaphylactic or anaphylactoid food allergy
- History of solid organ transplant
- Any condition jeopardizing safety, study completion, or data integrity
- Chronic kidney disease with GFR less than 60
- Urinary oxalate greater than or equal to 80 mg/day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 10 days
Participants in the initial treatment group undergo a run-in period before randomization.
Visits as needed during run-in
Duration - 10 days
Participants are treated with antibiotics for 3 days followed by microbial transplant therapy or placebo capsules taken twice daily for 7 days.
Approximately 2 visits (in-person)
Duration - Up to 5 weeks after treatment
Participants are followed to assess safety, adverse events, and changes in urinary parameters and microbiota.
Visits at weeks 1, 3, 4, and 5; plus telephone follow-up
Trial Site Locations
Total: 1 location
1
Park City Hospital
Park City, Utah, United States, 84060
Actively Recruiting
Research Team
D
Daniel Del Valle, MS
J
Joshua Stern, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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