What is Microbial Transplant Therapy studying for kidney stones?

Microbial Transplant Therapy is being studied to see how it affects urine substances linked to kidney stone formation. Researchers want to understand if changing gut bacteria can influence the levels of calcium and oxalate in urine for patients with recurrent stones. The study is sponsored by Joshua Stern and aims to improve knowledge about kidney stone management.

Who may be eligible for this kidney stones clinical trial?

Adults aged 18 to 69 with a history of kidney stones made mostly of calcium oxalate may be eligible. Participants need specific urine calcium or oxalate levels and must not be pregnant or taking certain medications. Please review eligibility criteria for more details.

Is there any cost to participate in this kidney stones clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should consider transportation costs when planning their involvement.

Actively Recruiting

Early Phase 1

Age: 18Years - 69Years

All Genders

ID05516472

Fecal Microbiota Transplant Therapy Using Capsules for Adults with Kidney Stones Early Phase 1 Study Measuring Urine Changes After Treatment

Led by Joshua Stern · Updated on 2025-03-10

Participants Needed

Research Sites

12 weeks

Total Duration

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 treatments effects on microbiota and stone-related urine measures.

CONDITIONS

Brief Title

Fecal Microbiota Transplantation in Kidney Stone Patients

Who Can Participate

Age: 18Years - 69Years

All Genders

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

Research Team

Daniel Del Valle, MS

Joshua Stern, MD

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Fecal Microbiota Transplant Therapy Using Capsules for Adults with Kidney Stones Early Phase 1 Study Measuring Urine Changes After Treatment

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria