Actively Recruiting
Fecal Microbiota Transplantation in Kidney Stone Patients
Led by Joshua Stern · Updated on 2025-03-10
36
Participants Needed
1
Research Sites
124 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
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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation in Kidney Stone Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and men age 18 to less than 70 years
- History of urinary stone disease with 50% or more calcium-oxalate stones confirmed by stone analysis
- 24-hour urinary calcium greater than 225 mg/day or oxalate greater than 40 mg/day
- Able to give informed consent
- Willing to participate in telephone follow-up for safety and adverse events
- Able and willing to complete study visits, 24-hour urine collection, and stool sample collection
- Not currently enrolled in another interventional urinary stone disease clinical trial
- Estimated Glomerular Filtration Rate (eGFR) of 60 or higher
You will not qualify if you...
- Having three or more features of metabolic syndrome as defined by NIH criteria
- Presence of autoimmune disease features
- Major gastrointestinal surgery (except appendectomy or cholecystectomy) within 3 months prior to enrollment
- Diagnosis of inflammatory bowel disease
- Diagnosed primary or secondary hyperparathyroidism with PTH outside 15-65 pg/ml range
- Requirement for pancreatic enzyme replacement therapy
- Undergoing dialysis treatment
- Received chemotherapy within the last year
- Antibiotic treatment within 3 months prior to study entry
- Use of potassium citrate, thiazides, or proton pump inhibitors within the last 6 months
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Inability or unwillingness to swallow capsules, including dysphagia grade 2 or higher
- Active gastrointestinal infection at enrollment
- Requires ongoing or anticipated antibiotic use within 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 active cancer
- Life expectancy less than 6 months
- Previous fecal microbiota transplant or microbiome-based therapy outside this study
- History of severe anaphylactic or anaphylactoid food allergy
- History of solid organ transplant
- Any condition that would risk safety, study completion, or confound study results
- Chronic kidney disease with GFR less than 60
- Urinary oxalate greater than or equal to 80 mg/day
AI-Screening
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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
CONTACT
J
Joshua Stern, MD
CONTACT
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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