Fecal Microbiota Transplantation for Kidney Stone Patients

Fecal Microbiota Transplantation (FMT CAPSULE DE, FMPCapDE, MTP-CP101) in Kidney Stone Patients (FMT IND STUDY)

This study is testing if a new treatment using healthy gut bacteria can help people with recurring kidney stones caused by high levels of calcium and oxalate in their urine.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Intermountain Health Care, Inc. (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Park City, Utah)
• Trial ID: NCT05516472 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a history of kidney stones composed of at least 50% calcium-oxalate and specific urinary parameters indicating hypercalciuria or hyperoxaluria.

Not a fit: Patients with metabolic syndrome or those currently participating in other interventional kidney stone studies may not benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from recurrent kidney stones.

How similar studies have performed: While the use of microbial transplant therapy is a novel approach in this context, similar studies in other conditions have shown promising results.

Eligibility criteria

Inclusion Criteria:

* Women and men age greater than or equal to 18 and less than 70
* Recent medical history of USD with greater than or equal to 50% calcium-oxalate stones. All patients will have urinary stone disease confirmed by stone analysis. The study will include patients with either stones extracted by urological intervention or spontaneously passed and collected stones.
* 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 undergo telephone follow-up to assess for safety and adverse events
* Willing and able to participate in the study requirements, including study visits, 24-hour urine collection and serial stool collection
* Not actively participating in another interventional USD clinical trial
* Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60.

Exclusion Criteria:

* Presence of three features of metabolic syndrome as defined by the NIH to have 3 or more of the following conditions:

  * Large waist - A waistline that measures at least 35 inches (89 centimeters) for women and 40 inches (102 centimeters) for men
  * High triglyceride level - 150 milligrams per deciliter (mg/dL), or 1.7 millimoles per liter (mmol/L), or higher of this type of fat found in blood
  * Reduced good or HDL cholesterol - Less than 40 mg/dL (1.04 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women of high-density lipoprotein (HDL) cholesterol
  * Increased blood pressure - 130/85 millimeters of mercury (mm Hg) or higher
  * Elevated fasting blood sugar - 100 mg/dL (5.6 mmol/L) or higher
* Presence of features of autoimmunity
* Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy
* Diagnosis of inflammatory bowel disease
* Patient diagnosed with primary hyperparathyroidism. Any patient with a PTH outside the range of 15 - 65 pg/ml will be excluded.
* Patient diagnosed secondary hyperparathyroidism. Any patient with a PTH outside the range of 15 - 65 pg/ml will be excluded.
* All patients requiring pancreatic enzyme replacement will be excluded.
* Patient with ongoing dialysis treatment
* Received chemotherapy treatment in the last 1 year
* Treatment with antibiotics within 3 months of study entry. If subjects need to take antibiotics unexpectedly during the trial, they are excluded if they have already taken the fecal material transplant; if not, they can re-enroll in 3 months.
* Patients taking potassium citrate, thiazides, or proton pump inhibitors in the last 6 months
* Women who are pregnant or breast-feeding or planning to get pregnant during the time of the study.
* Inability (e.g. dysphagia) to or unwilling to swallow capsules. Subjects with Grade greater than or equal to 2 dysphagia- as per Current Terminology for Common Adverse Events (CTCAE v 5.0) will be excluded.
* Active gastrointestinal infection at time of enrollment
* Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks
* Known or suspected toxic megacolon and/or known small bowel ileus
* History of total colectomy or bariatric surgery
* Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy
* Expected life expectancy less than 6 months
* Previous FMT or microbiome-based products at any time excluding this study
* Patients with a history of severe anaphylactic or anaphylactoid food allergy
* Solid organ transplant recipients (all patients with a history of solid organ transplant will be excluded).
* A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.
* Subjects will be excluded if they have chronic kidney disease defined as GFR (Glomerular Filtration Rate) less than 60.
* Subjects with urinary oxalate greater than or equal to 80 mg/d will be excluded

Where this trial is running

Park City, Utah

• Park City Hospital — Park City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Joshua Stern, MD — Intermountain Health Care, Inc.
• Study coordinator: Daniel Del Valle, MS

Conditions Kidney Stones; microbial transplant therapy; kidney stones