Fecal Microbiota Transplantation for Kidney Stone Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of Microbial Transplant Therapy (MTT) on urinary parameters in patients with recurrent kidney stones, specifically those with hypercalciuria and hyperoxaluria. Participants will undergo screening and baseline assessments, including a 24-hour urine collection to analyze various urinary components. The study will enroll 36 patients divided into four groups based on their urinary stone composition, with some receiving MTT and others receiving a placebo. Stool samples will also be collected for metagenomic analysis prior to the intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Park City Hospital
  Park City, Utah, United States Recruiting

Study contacts

• Principal investigator: Joshua Stern, MD — Intermountain Health Care, Inc.
• Study coordinator: Nic Unsworth
• Email: nic.unsworth@imail.org
• Phone: (801) 507-8280

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Outcomes and costs with the HugeMed 6.3 Fr flexible ureteroscope

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.