Fecal Microbiota Transplantation in Kidney Stone Patients

NCT05516472 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 1051917
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

microbial transplant therapy; kidney stones

Outcome Measures

Primary Outcomes (3)

• Proportion of participants with an adverse event

  Baseline to day 30 (plus or minus 3 days) after fecal transplant

• Changes in 24 hour urinary oxalate concentration

  Baseline to weeks 1, 3, and 5

• Changes in 24 hour urinary calcium concentration

  Baseline to week 1, 3, and 5

Secondary Outcomes (2)

• Metagenomic changes to subject microbiota pre-MTT

  Prior to fecal transplant (baseline)

• Metagenomic changes to subject microbiota post-MTT

  weeks 4 and 5 after MTT

Study Arms (4)

Hyperoxaluric group

EXPERIMENTAL

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

Drug: Microbial Transplant Therapy

Hypercalciuric Group

EXPERIMENTAL

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

Drug: Microbial Transplant Therapy

Control group Hyperoxaluria

PLACEBO COMPARATOR

Control group enrolling patients with hyperoxaluria

Drug: Placebo

Control group Hypercalciuria

PLACEBO COMPARATOR

Control group enrolling patients with hypercalciuria

Drug: Placebo

Interventions

Microbial Transplant Therapy DRUG

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

Also known as: fecal transplant

Hypercalciuric Group; Hyperoxaluric group

Placebo DRUG

Participants will take placebo capsules

Control group Hypercalciuria; Control group Hyperoxaluria

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joshua Stern: lead
• University of Minnesota: collaborator

Study Sites (1)

Park City Hospital

Park City, Utah, 84060, United States

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Joshua Stern, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Del Valle, MS

CONTACT

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

Joshua Stern, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Urology

Model Details: Prospective, randomized, placebo-controlled

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: October 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)