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Microbial Therapy

Fecal Microbiota Transplantation for Kidney Stones (FMT IND Trial)

Phase < 1

Recruiting

Led By Joshua Stern, MD

Research Sponsored by Joshua Stern

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recent medical history of USD with >60% calcium-oxalate stones confirmed by stone analysis

Recurrent urinary stone formers with a stone event in the preceding 24 months

Must not have

Diagnosis of colonic polyps on a diagnostic colonoscopy

Presence of features of metabolic syndrome as defined by the NIH

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial will study whether or not Microbial Transplant Therapy (MTT) is an effective treatment for recurrent kidney stones.

Who is the study for?

This trial is for adults aged 18-70 with a history of kidney stones, specifically those with high levels of calcium or oxalate in their urine. Participants must have had a stone event within the last two years and be able to perform study tasks like urine collection. Exclusions include individuals on dialysis, recent chemotherapy patients, those who've had certain surgeries or gastrointestinal conditions, pregnant women, and others with specific health issues.

What is being tested?

The trial is testing Microbial Transplant Therapy (MTT) against a placebo to see its effects on urinary factors related to kidney stone formation. Participants will either receive MTT or an inactive substance without knowing which one they're getting.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include digestive discomforts such as bloating or changes in bowel habits due to the introduction of new microbes into the gut from MTT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My recent kidney stones were mostly calcium-oxalate.

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I have had kidney stones again within the last 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with colonic polyps.

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I have been diagnosed with metabolic syndrome.

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I have had chemotherapy in the past year.

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I do not have an active stomach or intestine infection.

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I am currently receiving dialysis.

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I have had my entire colon removed or weight loss surgery.

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I have been taking potassium citrate, thiazides, or proton pump inhibitors in the last 6 months.

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I have or might have a severely enlarged colon or a blockage in my small intestine.

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I need to keep taking antibiotics or expect to start them soon.

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My parathyroid hormone levels are not between 11 - 51 pg/ml.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I am currently receiving intensive treatment for cancer.

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I have received a solid organ transplant.

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I have difficulty swallowing pills.

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I have been diagnosed with inflammatory bowel disease.

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I have never used FMT or microbiome products before this study.

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My kidney function is reduced with a GFR below 60.

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I haven't had major stomach or intestine surgery in the last 3 months.

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I need pancreatic enzyme supplements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Hyperoxaluric groupExperimental Treatment1 Intervention

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

Group II: Hypercalciuric GroupExperimental Treatment1 Intervention

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

Group III: Control group HyperoxaluriaPlacebo Group1 Intervention

Control group enrolling patients with hyperoxaluria

Group IV: Control group HypercalciuriaPlacebo Group1 Intervention

Control group enrolling patients with hypercalciuria

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

Litholink CorporationUNKNOWN

Joshua SternLead Sponsor

University of MinnesotaOTHER

1,434 Previous Clinical Trials

1,621,666 Total Patients Enrolled

2 Trials studying Kidney Stones

128 Patients Enrolled for Kidney Stones

Media Library

Microbial Transplant Therapy (Microbial Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05516472 — Phase < 1

Kidney Stones Research Study Groups: Hyperoxaluric group, Hypercalciuric Group, Control group Hyperoxaluria, Control group Hypercalciuria

Kidney Stones Clinical Trial 2023: Microbial Transplant Therapy Highlights & Side Effects. Trial Name: NCT05516472 — Phase < 1

Microbial Transplant Therapy (Microbial Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05516472 — Phase < 1

~24 spots leftby Dec 2026

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