FMT IND: Fecal Microbiota Transplantation in Kidney Stone Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
In this study, urinary stone disease patients will be recruited from the Park City Urology Clinic at Intermountain Healthcare.
Subjects will undergo screening and baseline assessments, including a history and physical exam. A 24-hour urine sample will be collected. Urinary parameters include analysis for calcium, oxalate, uric acid, citrate, NH4, sulfate, pH, Cr, phosphate, sodium, potassium, magnesium, super saturation (SS) CaOx, SSUA, SSCaP, UUN.
Microbial Transplant Therapy (MTT), the intervention, will be offered to individuals who produce greater than 60% calcium-oxalate stones. Pathology reports in the patient's medical record will be used to confirm the stone composition. The cohort of 36 total enrollees will be comprised of three separate study groups of 12 each. The first group of 12 will include hyperoxaluric patients, the second group of 12 will include hypercalciuric patients and the third group will enroll patients with either hyperoxaluria or hypercalciuria as our control group. Grouping will be determined by 24-hour urine analysis which show measurements of urinary calcium >225mg/day (hypercalciuric group) and oxalate >40mg/day (hyperoxaluric group).
Stool samples will be obtained for metagenomic analyses prior to the intervention.
Subjects will be assigned to the hypercalciuric and hyperoxaluric arms based upon urine parameters or placed in the control arm by random assignment. Because antibiotic treatment is common during surgery for stones, participants will be treated with 3 days of vancomycin 500 mg orally twice a day and neomycin 1,000 mg orally twice a day. Twenty-four hours later, participants will take either the control capsule or the microbial capsules, 2 capsules daily for 7 days.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hyperoxaluric group Treatment group based on 24 hour urine analysis showing oxalate >40 mg/day. |
Drug: Microbial Transplant Therapy
Participants will take microbial capsules, 2 capsules daily for 7 days
Other Names:
|
| Experimental: Hypercalciuric Group Treatment group based on 24 hour urine analysis showing urinary calcium >225 mg/day. |
Drug: Microbial Transplant Therapy
Participants will take microbial capsules, 2 capsules daily for 7 days
Other Names:
|
| Placebo Comparator: Control group Control group enrolling patients with either hyperoxaluria or hypercalciuria |
Drug: Placebo
Participants will take placebo capsules
|
Outcome Measures
Primary Outcome Measures
- Changes in 24 hour urinary oxalate concentration [Baseline to weeks 3, 4, and 5]
- Changes in 24 hour urinary calcium concentration [Baseline to week 3, 4, and 5]
- Proportion of participants with an adverse event [Baseline to day 30 (plus or minus 3 days) after fecal transplant]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women and men age >18 and <70
-
Recent medical history of USD with >60% calcium-oxalate stones
-
24-hour urinary calcium concentration >225 mg/day or urinary oxalate >40 mg/day
-
Able to give informed consent.
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Willing to undergo telephone follow-up to assess for safety and adverse events
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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
Exclusion Criteria:
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Presence of features of metabolic syndrome
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Presence of features of autoimmunity
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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
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Patient diagnosed with primary hyperparathyroidism
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Patient diagnosed secondary hyperparathyroidism
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Patient with ongoing dialysis treatment
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Received chemotherapy treatment in the last 1 year
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Treatment with antibiotics within 4 months of study entry
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Patients taking potassium citrate, thiazides, or proton pump inhibitors in the last 6 months
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Women who are pregnant or breast-feeding or planning to get pregnant during the time of the study.
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Inability (e.g. dysphagia) to or unwilling to swallow capsules
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Active gastrointestinal infection at time of enrollment
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Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks
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Known or suspected toxic megacolon and/or known small bowel ileus
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History of total colectomy or bariatric surgery
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Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy
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Expected life expectancy < 6 months
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Previous FMT or microbiome-based products at any time excluding this study
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Patients with a history of severe anaphylactic or anaphylactoid food allergy
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Solid organ transplant recipients less than or equal to 90 days post-transplant or on active treatment for rejection
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Park City Hospital | Park City | Utah | United States | 84060 |
Sponsors and Collaborators
- Joshua Stern
- University of Minnesota
- Albert Einstein College of Medicine
- Litholink Corp
Investigators
- Principal Investigator: Joshua Stern, MD, Intermountain Health Care, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1051917