Recruiting
Early Phase 1

Microbial Transplant Therapy

Sponsor:

Joshua Stern

Code:

NCT05516472

Conditions

Kidney Stones

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

Interventions

Microbial Transplant Therapy

Placebo

Study Details

Brief summary:

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

Kidney Stones

Study ID

NCT05516472

Start date

Oct 10, 2024

Status verified date

Feb, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Hyperoxaluric group

Treatment group based on 24 hour urine analysis showing oxalate >40 mg/day.

experimental: Hypercalciuric Group

Treatment group based on 24 hour urine analysis showing urinary calcium >225 mg/day.

placebo comparator: Control group Hyperoxaluria

Control group enrolling patients with hyperoxaluria

placebo comparator: Control group Hypercalciuria

Control group enrolling patients with hypercalciuria

Interventions

Microbial Transplant Therapy

Participants will take microbial capsules, 2 capsules daily for 7 days

Placebo

Participants will take placebo capsules

Primary outcome measure

  • Proportion of participants with an adverse event [ Time Frame: Baseline to day 30 (plus or minus 3 days) after fecal transplant ]
  • Changes in 24 hour urinary oxalate concentration [ Time Frame: Baseline to weeks 1, 3, and 5 ]
  • Changes in 24 hour urinary calcium concentration [ Time Frame: Baseline to week 1, 3, and 5 ]

Central Contacts and Locations

Central contacts

Daniel Del Valle, MS

(801) 507-9421daniel.delvalle@imail.org

Joshua Stern, MD

(435) 658-7400joshua.stern@imail.org

Locations

Park City Hospital

Recruiting

Park City, Utah, United States, 84060

Contacts

Joshua Stern, MD

(435) 658-7400joshua.stern@imail.org

Daniel Del Valle, MS

(801) 507-9421Daniel.DelValle@imail.org

Principal Investigator:

Joshua Stern, MD

More Information

Sponsor

Joshua Stern

Last update posted

Mar 10, 2025

Last verified

Feb, 2025

Keywords

  • microbial transplant therapy
  • kidney stones

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Joshua Stern on 2025-03-10.