Fecal Microbiota Transplantation for Kidney Stones

(FMT IND Trial)

Overseen By Joshua Stern, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Joshua Stern

Must not be taking: Potassium citrate, Thiazides, PPIs

Disqualifiers: Metabolic syndrome, Autoimmunity, IBD, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Microbial Transplant Therapy (MTT) can alter certain urine factors in individuals who frequently develop kidney stones primarily composed of calcium oxalate. The treatment uses healthy bacteria to potentially improve mineral processing in the body. The trial includes various groups, such as those with high calcium or oxalate levels in their urine, and control groups receiving a placebo. Candidates may qualify if they have experienced kidney stones with elevated calcium or oxalate levels in their urine and can provide urine and stool samples for the study. As an Early Phase 1 trial, this research aims to understand how the treatment functions in people, offering participants the chance to be among the first to receive this innovative therapy.

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.

Is there any evidence suggesting that Microbial Transplant Therapy is likely to be safe for humans?

Research shows that Microbial Transplant Therapy (MTT), also known as fecal microbiota transplantation, is usually well-tolerated. In one study, patients with IgA nephropathy received this treatment without major side effects, suggesting its safety. Other studies indicate that MTT can help reduce harmful conditions in rats, such as kidney crystal deposits.

As this trial is in the early stages, safety information continues to be collected. However, current evidence suggests MTT is promising and generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney stones?

Researchers are excited about microbial transplant therapy for kidney stones because it uses a unique approach to tackle the problem at its root. Unlike traditional treatments like medications that alter urine chemistry or surgical procedures to remove stones, this therapy focuses on modifying gut bacteria to reduce the body's production of stone-forming compounds like oxalate and calcium. By introducing beneficial microbes through a fecal microbiota transplant, the treatment aims to create a healthier balance in the gut, potentially reducing stone formation naturally and offering a long-term solution. This novel mechanism of action could revolutionize how kidney stones are managed, providing an alternative that targets the cause rather than just the symptoms.

What evidence suggests that Microbial Transplant Therapy could be an effective treatment for kidney stones?

Research shows that fecal microbiota transplantation (FMT), a treatment studied in this trial, might help with kidney problems. Studies have found that FMT can lower calcium oxalate levels in the kidneys, which often cause kidney stones. In animal studies, FMT restored healthy gut bacteria, possibly reducing the risk of stones. Although more research is needed in humans, early results suggest that changing gut bacteria through FMT might help manage conditions like high calcium and oxalate levels in urine, both linked to kidney stones. This treatment aims to improve the balance of gut microbes, potentially lowering the risk of kidney stones. Participants in this trial may receive FMT or a placebo, depending on their assigned treatment group. ^{1 2 4 6 7}

Who Is on the Research Team?

Joshua Stern, MD

Principal Investigator

Intermountain Health Care, Inc.

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Hyperoxaluric group Experimental Treatment 1 Intervention

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

Group II: Hypercalciuric Group Experimental Treatment 1 Intervention

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

Group III: Control group Hyperoxaluria Placebo Group 1 Intervention

Control group enrolling patients with hyperoxaluria

Group IV: Control group Hypercalciuria Placebo Group 1 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

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+

Published Research Related to This Trial

Fecal microbiota transplantation (FMT) is highly effective for treating Clostridium difficile infection (CDI), with a 90% resolution of diarrhea reported in 867 patients across 33 studies, and a 94% resolution after repeated FMT in a randomized controlled trial with 16 participants.

FMT shows promise in treating ulcerative colitis, with remission rates varying from 0% to 68% in 106 patients, while its efficacy in Crohn's disease, chronic constipation, pouchitis, and irritable bowel syndrome remains inconclusive due to limited data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. Rossen, NG., MacDonald, JK., de Vries, EM., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Aspects of Fecal Microbial Transplantation (FMT). Bhutiani, N., Schucht, JE., Miller, KR., et al.[2018]

Fecal microbiota transplantation (FMT) is a safe and effective treatment for recurrent Clostridium difficile infections, and research is expanding to explore its potential for treating other conditions related to chronic inflammation and autoimmunity.

Current studies on FMT for conditions like ulcerative colitis and metabolic syndrome show promise, but many lack rigorous methodology, highlighting the need for more standardized and well-designed trials to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fecal microbiota transplantation : current status and prospects]. Gilbert, B., Schrenzel, J.[2019]

Fecal microbiota transplantation (FMT) successfully induced and maintained clinical remission in a patient with ulcerative colitis (UC) who was allergic to 5-aminosalicylic acid (5-ASA), demonstrating its potential as an alternative treatment.

This case highlights the efficacy of FMT in reconstructing intestinal microbiota for patients with refractory UC, especially when conventional treatments like steroid therapy fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation treatment for refractory ulcerative colitis with allergy to 5-aminosalicylic acid: A case report. Wang, HG., Liu, SP., Ma, TH., et al.[2021]

Fecal transplants from Zucker lean rats to germ-free mice significantly reduced urinary calcium by 55% and urinary oxalate levels by 24%, suggesting that gut microbiome composition can influence urinary stone disease risk factors.

The study found a 90% increase in the expression of the Slc26a6 transporter, which is involved in oxalate balance, indicating that the gut microbiome may play a crucial role in metabolic processes that affect urinary chemistry and stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal transplant modifies urine chemistry risk factors for urinary stone disease. Stern, JM., Urban-Maldonado, M., Usyk, M., et al.[2023]

About 80% of kidney stones are made of calcium oxalate, and the gut microbiome may influence their formation and prevention.

Specific gut bacteria, such as Oxalobacter formigenes, Bifidobacterium, and Lactobacillus, are linked to calcium oxalate stones, suggesting that modifying gut flora could be a new approach to prevent kidney stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of intestinal flora on calcium oxalate stones. Wang, C., Dong, X., Yin, X., et al.[2021]

Oxalobacter formigenes, a known oxalate-degrading bacterium, does not effectively predict the risk of urinary stone disease (USD) or urinary oxalate levels, suggesting limitations in current probiotic approaches.

A meta-analysis revealed that shifts in the overall gut microbiota are significantly associated with USD, indicating that effective bacteriotherapy should target a diverse range of gut bacteria rather than just a few specific species.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium Oxalate Urolithiasis: A Case of Missing Microbes? Batagello, CA., Monga, M., Miller, AW.[2019]

Oxalobacter formigenes, a beneficial bacterium that helps prevent calcium oxalate kidney stones, was found in only 31% of healthy young adults in the U.S., indicating that it is not present in the majority of this population.

When O. formigenes was detected, it showed a high stability of colonization, with 93% of individuals remaining positive for the bacterium at follow-up visits, suggesting its potential role in long-term kidney stone prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Presence of Oxalobacter formigenes in the Microbiome of Healthy Young Adults. Barnett, C., Nazzal, L., Goldfarb, DS., et al.[2018]

Fecal microbiota transplantation (FMT) has a total adverse event (AE) incidence rate of 28.5%, with abdominal discomfort being the most common AE reported in 19 studies, highlighting the need for careful monitoring during the procedure.

Serious adverse events (SAEs) occurred in 9.2% of patients, with a notable incidence of death (3.5%) and infections (2.5%), indicating that while FMT can be beneficial, it carries significant risks that require further investigation through high-quality randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review: Adverse Events of Fecal Microbiota Transplantation. Wang, S., Xu, M., Wang, W., et al.[2023]

A study screened 2071 potential stool donors for fecal microbiota transplantation (FMT) in China, resulting in a low selection rate of 3.19%, highlighting the challenges in finding suitable donors.

The research established a donor microbial evaluation index (DoMEI) to improve the screening process, ensuring safety and stability of gut microbiota, which is crucial for the effectiveness of FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive approach to stool donor screening for faecal microbiota transplantation in China. He, J., He, X., Ma, Y., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in a kidney transplant recipient with recurrent urinary tract infection. Biehl, LM., Cruz Aguilar, R., Farowski, F., et al.[2019]

Fecal microbiota transplantation (FMT) is a therapeutic procedure that involves transferring fecal matter from a healthy donor to treat diseases, particularly recurrent Clostridium difficile infections.

Recent research highlights the importance of the human microbiome, showing that the complex mixture of microorganisms in our bodies plays a crucial role in overall health and disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. Aroniadis, OC., Brandt, LJ.[2022]

Fecal microbiome transplantation (FMT) in male guinea pigs and Sprague-Dawley rats significantly reduced urinary oxalate levels and calcium oxalate crystal deposition in the kidneys, suggesting a potential therapeutic role for FMT in preventing kidney stones.

The study identified a beneficial microbial network activated by FMT, including bacteria like Muribaculaceae and Lactobacillus, which enhanced intestinal oxalate degradation and may provide a protective effect against oxalate-related kidney damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wang, Y., Sun, J., Xie, S., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 30 patients with ulcerative colitis who did not respond to standard treatments, 70% showed a clinical response to fecal microbial transplantation (FMT) after 12 weeks, with 43.3% achieving both clinical and endoscopic remission.

FMT was found to be a safe alternative to immunosuppressive therapies, with only mild adverse events reported in 23.3% of patients, suggesting it could be a promising option for those with refractory ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. Uygun, A., Ozturk, K., Demirci, H., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05516472

Fecal Microbiota Transplantation in Kidney Stone Patients Forty-eight to 72 hours later, participants will take either the control capsule or the microbial capsules, 2 capsules daily for 7 days. Official Title. Fecal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12283619/

Fecal microbiota transplantation is a promising therapy for ... Fecal microbiota transplantation (FMT), a direct method of reconstructing gut microbial communities, has demonstrated promise in CKD by targeting mechanisms ...

3. nature.com nature.com/articles/s41598-024-72694-4

Unraveling the role of gut microbiota by fecal ... This study investigates the effects of gut dysbiosis on urolithiasis through fecal microbiota transplantation (FMT) from patients to rats

4. journals.asm.org journals.asm.org/doi/10.1128/msystems.00810-25

Human fecal microbiota transplantation attenuates high ... Although several studies have indicated that fecal microbiota transplantation from healthy animals can effectively reduce renal calcium oxalate ...

5. gutpathogens.biomedcentral.com gutpathogens.biomedcentral.com/articles/10.1186/s13099-025-00705-4

Fecal microbiota transplantation alleviates ... - Gut Pathogens Fecal microbiota transplantation alleviates immunosuppressant-associated diarrhea and recurrent urinary tract infection in kidney transplant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12455927/

Human fecal microbiota transplantation attenuates high ... By transplanting healthy human gut microbiota into HDOx rats, we found that hFMT significantly reduced CaOx crystal depositions and kidney ...

7. nature.com nature.com/articles/s41598-024-74171-4

Safety and efficacy assessment of fecal microbiota ... This study preliminarily evaluates the safety and efficacy of FMT in patients with IgAN. No significant adverse reactions were observed.