Fecal Microbiota Transplantation for Kidney Stones
(FMT IND Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJoshua Stern, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Joshua Stern
Must not be taking: Potassium citrate, Thiazides, PPIs
Disqualifiers: Metabolic syndrome, Autoimmunity, IBD, others
Approved in 3 Jurisdictions
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?
Is fecal microbiota transplantation (FMT) safe for humans?
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
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
I am between 18 and 70 years old.
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
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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
Trial 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 (Microbial Therapy)
- Placebo (Other)
Trial OverviewThe 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
Research Locations NearbySelect from list below to view details:
Park City HospitalPark City, UT
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Who Is Running the Clinical Trial?
Joshua SternLead Sponsor
Litholink CorporationCollaborator
University of MinnesotaCollaborator
Albert Einstein College of MedicineCollaborator
Litholink CorpCollaborator
References
Technical Aspects of Fecal Microbial Transplantation (FMT). [2018]Fecal microbial transplantation (FMT) has become established as an effective therapeutic modality in the treatment of antibiotic-refractory recurrent Clostridium difficile colitis. A number of formulations and methods of delivery of FMT are currently available, each with distinct advantages. This review aims to review donor and patient selection for FMT as well as procedural aspects of FMT to help guide clinical practice.
Fecal microbiota transplantation in a kidney transplant recipient with recurrent urinary tract infection. [2019]We report on a kidney transplant recipient treated with fecal microbiota transplantation (FMT) for recurrent urinary tract infections.
Time series strain tracking analysis post fecal transplantation identifies individual specific patterns of fecal dominant donor, recipient, and unrelated microbial strains. [2022]Fecal microbial transplantation (FMT) has been used with the therapeutic intent to change the functions of the gut microbial community in metabolism and host immunity. For most of these therapies, the recipients are not given antibiotics to eliminate the microbial community prior to transplant with donor fecal microbes resulting in the initial gut microbial community following FMT consisting of a consortium of donor and recipient microbes. The detailed analysis of the fecal samples from these FMT over time provides a unique opportunity to study the changes in the gut microbial strain community that occurs following the introduction of new microbial strains (donor) into an established community (recipient).
Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. [2022]Fecal microbiota transplantation (FMT) refers to the infusion of a fecal suspension from a healthy person into the gastrointestinal (GI) tract of another person to cure a specific disease. FMT is by no means a new therapeutic modality, although it was only relatively recently that stool was shown to be a biologically active, complex mixture of living organisms with great therapeutic potential for recurrent Clostridium difficile infection and perhaps other GI and non-GI disorders. The published revelations about the human microbiome are bringing the strength of science to clinical observation and enhancing the understanding of not only disease but also how much of a person's daily function and health depends on the microorganisms living in intimate relationship with each cell in the body.
Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. [2018]Fecal microbial transplantation (FMT) provides to replace beneficial bacteria with more favorable microbiomes in recipient with dysbiosis. The aim of the present study was to prospectively investigate the efficacy of FMT by assessing the clinical and endoscopic response in patients with ulcerative colitis (UC) who had failed anti-inflammatory and immunosuppressive therapy.
Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. [2022]To study the clinical efficacy and safety of Fecal microbiota transplantation (FMT). We systematically reviewed FMT used as clinical therapy.
Systematic Review: Adverse Events of Fecal Microbiota Transplantation. [2023]Fecal microbiota transplantation (FMT) is a microbiota-based therapy that shows therapeutic potential in recurrent or refractory Clostridium difficile infections and other intestinal or extra-intestinal disorders. Nonetheless, adverse events (AEs) remain a major challenge in the application of FMT.
[Fecal microbiota transplantation : current status and prospects]. [2019]Fecal microbiota transplantation (FMT) is approved as a safe and effective treatment of recurrent Clostridium difficile infections. The technique is now being studied for other indications, usually involving chronic inflammation, metabolic disorders, or autoimmunity, for which the gut microbiota appears to play a key role. We detail thereafter, according to their degree of evidence, the potential future indications, in which FMT has already been tried on Humans. Except for ulcerative colitis and metabolic syndrome, the methodology of the published trials is often insufficiently described and inhomogeneous. Further randomized placebo-controlled trials and standardization of practice will be needed to confirm these preliminary but encouraging results.
Fecal microbiota transplantation treatment for refractory ulcerative colitis with allergy to 5-aminosalicylic acid: A case report. [2021]Fecal microbiota transplantation (FMT) is currently being explored as a potential therapy for ulcerative colitis (UC). Here, we report the first case of a UC patient with allergy to 5-aminosalicylic acid (5-ASA) who underwent FMT and achieved clinical remission.
A comprehensive approach to stool donor screening for faecal microbiota transplantation in China. [2022]Faecal microbiota transplantation (FMT) is an effective therapy for recurrent Clostridium difficile infections and chronic gastrointestional infections. However, the risks of FMT and the selection process of suitable donors remain insufficiently characterized. The eligibility rate for screening, underlying microbial basis, and core ethical issues of stool donors for FMT are yet to be elucidated in China.
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]The incidence of nephrolithiasis is increasing rapidly worldwide. Calcium oxalate is the most common constituent, contributing to approximately 80% of all kidney stones. The gut microbiome, through its oxalate-degrading ability, may play a role in decreasing morbidity due to urinary calculus. Fecal microbiome transplantation (FMT) has been reported to be effective in restoring the gastrointestinal microbial community in different conditions. The transplantation of whole communities that have oxalate-degrading function may be a more effective strategy than the transplantation of isolated strains.
Fecal transplant modifies urine chemistry risk factors for urinary stone disease. [2023]Urinary stone disease (USD) is a major health concern. There is a need for new treatment modalities. Recently, our group provided evidence for an association between the GMB composition and USD. The accessibility of the Gut Microbiome (GMB) makes it an attractive target for investigation and therefore, in these studies we have evaluated the extent to which the whole gut microbial community in fecal transplants can affect urinary stone risk parameters in an animal model. Fresh fecal pellets were collected from Zucker lean rats, homogenized in PBS (100 mg/mL), filtered through a 70 μm strainer and then orally gavaged into C57BL/6NTac germ-free mice. Twenty-four hours urine collections and GMB analysis were performed over time for 1 month. Kidney and gut tissue were harvested from transplanted mice for western blot analysis of expression levels of the Slc26a6 transporter involved in oxalate balance. Urinary calcium decreased after fecal transplant by 55% (P
Impact of intestinal flora on calcium oxalate stones. [2021]Kidney stone is one of the common diseases of the urinary system. About 80% of kidney stones are mainly composed of calcium oxalate. As a huge bacterial network, the interaction of gut microbes is complex. Intestinal microbes may play a role in the pathogenesis and prevention of kidney stones. The intestinal flora of patients with calcium oxalate stones possess unique distribution of gut microbes. Oxalobacter formigenes, Bifidobacterium, Lactobacillus, Escherichia coli, and Providencia reteri bacteria are closely related to calcium oxalate stones, which provides new ideas for the prevention and treatment of urinary stones.
Calcium Oxalate Urolithiasis: A Case of Missing Microbes? [2019]Urinary stone disease (USD) has known associations with the gut microbiota. Approximately 80% of kidney stones contain oxalate as a primary constituent and diverse oxalate-degrading bacteria exist within the human gut, which may protect against USD. Although bacteriotherapy represents a promising strategy to eliminate oxalate and reduce the risk of USD, oxalate-degrading probiotics have had limited success. To identify limitations of oxalate-degrading probiotics and refine development of bacteriotherapies to prevent USD, we review the literature associated with the gut microbiota and USD.
The Presence of Oxalobacter formigenes in the Microbiome of Healthy Young Adults. [2018]Oxalobacter formigenes, a member of the human colonic microbiota with a major role in net colonic oxalate transport and secretion, is protective against the formation of calcium oxalate kidney stones. We describe the prevalence, relative abundance and stability of O. formigenes in healthy young adults in the United States.