36 Participants Needed

Fecal Microbiota Transplantation for Kidney Stones

(FMT IND Trial)

AI
AH
DD
JS
Overseen ByJoshua Stern, MD
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants have not taken potassium citrate, thiazides, or proton pump inhibitors in the last 6 months. Additionally, you cannot have taken antibiotics within 3 months before the study or require continued antibiotic use during the study.

What data supports the effectiveness of the treatment Fecal Microbiota Transplantation for Kidney Stones?

Fecal Microbiota Transplantation (FMT) has shown effectiveness in treating recurrent Clostridium difficile infections and ulcerative colitis by introducing healthy bacteria into the gut, which suggests it might help with other conditions by improving gut health and immune function.12345

Is fecal microbiota transplantation (FMT) safe for humans?

Fecal microbiota transplantation (FMT) is generally considered safe for treating recurrent Clostridium difficile infections, but there are still challenges with adverse events (unwanted side effects) and donor screening. More research is needed to confirm its safety for other conditions.678910

How is fecal microbiota transplantation different from other treatments for kidney stones?

Fecal microbiota transplantation (FMT) is unique because it involves transferring a whole community of gut bacteria, which can degrade oxalate, a major component of most kidney stones. This approach targets the gut microbiome to reduce stone formation, unlike traditional treatments that focus on managing symptoms or removing stones.1112131415

Research Team

JS

Joshua Stern, MD

Principal Investigator

Intermountain Health Care, Inc.

Eligibility Criteria

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.

Inclusion Criteria

Not actively participating in another interventional USD clinical trial
Willing and able to participate in the study requirements, including study visits, 24-hour urine collection and serial stool collection
I agree to phone calls to check on my health and side effects.
See 5 more

Exclusion Criteria

I have been diagnosed with metabolic syndrome.
I have had chemotherapy in the past year.
I have not taken antibiotics in the last 3 months.
See 23 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Baseline assessments including history, physical exam, and 24-hour urine sample collection

1 week
1 visit (in-person)

Run-in Period

Initial treatment of 7-10 patients to begin the study

1-2 weeks

Randomization and Treatment

Participants are randomized into treatment or control groups and receive antibiotics followed by capsules

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Microbial Transplant Therapy
  • Placebo
Trial Overview 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.
Participant Groups
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

Microbial Transplant Therapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Fecal Microbiota Transplantation for:
  • Recurrent Clostridioides difficile infection
🇪🇺
Approved in European Union as Fecal Microbiota Transplantation for:
  • Recurrent Clostridioides difficile infection
🇨🇦
Approved in Canada as Fecal Microbiota Transplantation for:
  • Recurrent Clostridioides difficile infection

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joshua Stern

Lead Sponsor

Trials
1
Recruited
40+

Litholink Corporation

Collaborator

Trials
1
Recruited
40+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

Albert Einstein College of Medicine

Collaborator

Trials
302
Recruited
11,690,000+

Litholink Corp

Collaborator

Trials
1
Recruited
40+

Findings from Research

Fecal microbial transplantation (FMT) is an effective treatment for recurrent Clostridium difficile colitis, with various delivery methods such as oral ingestion, colonoscopy, and enemas tailored to patient needs.
Careful selection of donors and patients is essential to ensure safety and efficacy, as FMT is being explored for potential treatment of other conditions beyond just C. difficile infections.
Technical Aspects of Fecal Microbial Transplantation (FMT).Bhutiani, N., Schucht, JE., Miller, KR., et al.[2018]
A kidney transplant recipient successfully treated recurrent urinary tract infections with fecal microbiota transplantation (FMT), remaining symptom-free after the procedure.
The study highlights the need for further research to understand the underlying mechanisms of how FMT works in this context.
Fecal microbiota transplantation in a kidney transplant recipient with recurrent urinary tract infection.Biehl, LM., Cruz Aguilar, R., Farowski, F., et al.[2019]
Fecal microbial transplantation (FMT) can lead to complex changes in the gut microbial community, with patterns of dominance shifting between donor and recipient strains over time, as observed in a study analyzing samples from 5 FMTs over up to 535 days.
The study identified potential recombination events between donor and recipient strains, particularly in Bacteroides vulgatus, suggesting that FMT not only introduces new microbes but can also lead to interactions that may affect gut metabolism and immunity.
Time series strain tracking analysis post fecal transplantation identifies individual specific patterns of fecal dominant donor, recipient, and unrelated microbial strains.Koo, H., Morrow, CD.[2022]

References

Technical Aspects of Fecal Microbial Transplantation (FMT). [2018]
Fecal microbiota transplantation in a kidney transplant recipient with recurrent urinary tract infection. [2019]
Time series strain tracking analysis post fecal transplantation identifies individual specific patterns of fecal dominant donor, recipient, and unrelated microbial strains. [2022]
Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. [2022]
Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. [2018]
Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. [2022]
Systematic Review: Adverse Events of Fecal Microbiota Transplantation. [2023]
[Fecal microbiota transplantation : current status and prospects]. [2019]
Fecal microbiota transplantation treatment for refractory ulcerative colitis with allergy to 5-aminosalicylic acid: A case report. [2021]
A comprehensive approach to stool donor screening for faecal microbiota transplantation in China. [2022]
Increased abundance of bacteria of the family Muribaculaceae achieved by fecal microbiome transplantation correlates with the inhibition of kidney calcium oxalate stone deposition in experimental rats. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Fecal transplant modifies urine chemistry risk factors for urinary stone disease. [2023]
Impact of intestinal flora on calcium oxalate stones. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Calcium Oxalate Urolithiasis: A Case of Missing Microbes? [2019]
15.United Statespubmed.ncbi.nlm.nih.gov
The Presence of Oxalobacter formigenes in the Microbiome of Healthy Young Adults. [2018]