Kidney StonesEarly Phase 1FMT INDNCT05516472
Fecal Microbiota Transplantation in Kidney Stone Patients
A Early Phase 1 study testing Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101) and Vancomycin and neomycin antibiotic pretreatment in people with Kidney Stones and Urinary Stone Disease / Nephrolithiasis, run by Joshua Stern at 1 site in United States.
Trial summary
This open-label pilot study evaluates whether oral microbial transplant therapy can change urine factors associated with recurrent calcium-oxalate kidney stones. Adults with high urine calcium or high urine oxalate will receive antibiotic pretreatment followed by microbial capsules. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Kidney Stones, Urinary Stone Disease / Nephrolithiasis, Recurrent Calcium-oxalate Kidney Stones
- What is being tested?
- Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101) and Vancomycin and neomycin antibiotic pretreatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2024to Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older and younger than 70 years.
- Recent urinary stone disease with at least 50% calcium-oxalate composition confirmed by stone analysis.
- 24-hour urinary calcium >225 mg/day or urinary oxalate >40 mg/day.
- Able to provide informed consent.
- Willing to complete safety follow-up, study visits, 24-hour urine collections, and serial stool collections.
- Not actively participating in another interventional urinary stone disease trial.
- eGFR >=60.
Who cannot join
- Three or more NIH-defined metabolic syndrome features.
- Any autoimmune disease or inflammatory bowel disease.
- Major gastrointestinal surgery within 3 months, excluding appendectomy or cholecystectomy; history of total colectomy or bariatric surgery.
- Primary or secondary hyperparathyroidism or PTH outside 15-65 pg/mL.
- Pancreatic enzyme replacement, ongoing dialysis, or eGFR <60.
- Chemotherapy in the prior year or concurrent intensive cancer therapy.
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- Antibiotics within 3 months of study entry, continued antibiotic need, or anticipated antibiotic use in the next 4 weeks.
- Unable to complete required washout from potassium citrate, thiazides, or proton pump inhibitors.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Unable or unwilling to swallow capsules, including CTCAE grade >=2 dysphagia.
- Active gastrointestinal infection, toxic megacolon, or small bowel ileus.
- Life expectancy <6 months.
- Prior FMT or microbiome-based product outside this study.
- Severe anaphylactic or anaphylactoid food allergy.
- Solid organ transplant recipient.
- Any condition jeopardizing safety or rights, preventing completion, or confounding results.
- Urinary oxalate >=80 mg/day.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Park City Hospital
Park City, Utah, 84060
Joshua Stern, MD, (435) 658-7400, joshua.stern@imail.org
Anne Haroldsen, MHA, (801) 507-9415, Anne.Haroldsen@imail.org
About this study
Official title: Fecal Microbiota Transplantation (FMT CAPSULE DE, FMPCapDE, MTP-CP101) in Kidney Stone Patients (FMT IND STUDY)
This open-label pilot study evaluates whether oral microbial transplant therapy can change urine factors associated with recurrent calcium-oxalate kidney stones. Adults with high urine calcium or high urine oxalate will receive antibiotic pretreatment followed by microbial capsules. Changes in 24-hour urine calcium and oxalate and treatment safety will be assessed.
Read the detailed description
Participants with recurrent calcium-oxalate stones are assigned to a hyperoxaluric or hypercalciuric cohort based on baseline 24-hour urine results. All participants receive vancomycin 500 mg twice daily and neomycin 1,000 mg twice daily for 3 days. Forty-eight to 72 hours later, they take 2 microbial transplant therapy capsules daily for 7 days. Urine and stool samples are collected at baseline, after antibiotics, and during follow-up. Participants serve as their own controls. Follow-up includes weekly contacts through Week 5, telephone/record review at Months 2-6, and record review at Months 9 and 12
- Conditions
- Kidney Stones, Urinary Stone Disease / Nephrolithiasis, Recurrent Calcium-oxalate Kidney Stones
- Being tested
- Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101), Vancomycin and neomycin antibiotic pretreatment
- Keywords
- microbial transplant therapy, kidney stones
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101)Drug
Also called fecal transplant
Two capsules orally once daily for 7 days, beginning 48-72 hours after completion of antibiotic pretreatment.
Vancomycin and neomycin antibiotic pretreatmentDrug
Vancomycin 500 mg orally twice daily and neomycin 1,000 mg orally twice daily for 3 days before MTT.
| Study group | Role | What they receive |
|---|---|---|
| Hyperoxaluric group | Experimental | Participants with urinary oxalate >40 mg/day and <80 mg/day receive antibiotic pretreatment followed by MTT, 2 capsules daily for 7 days. Receives: Drug: Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101); Drug: Vancomycin and neomycin antibiotic pretreatment |
| Hypercalciuric Group | Experimental | Participants with urinary calcium >225 mg/day receive antibiotic pretreatment followed by MTT, 2 capsules daily for 7 days Receives: Drug: Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101); Drug: Vancomycin and neomycin antibiotic pretreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour urinary oxalate concentration from baseline
Within-participant change in urinary oxalate concentration measured in 24-hour urine collections.
Measured: Baseline to Weeks 1, 3, and 5
Change in 24-hour urinary calcium concentration from baseline
Within-participant change in urinary calcium concentration measured in 24-hour urine collections.
Measured: Baseline to weeks 1, 3, and 5
Proportion of participants with an adverse event
Safety assessed as the proportion of participants experiencing an adverse event through the specified follow-up period.
Measured: Through Day 30 (+/- 3 days) after MTT
Secondary outcomes (1)
Metagenomic changes in participant microbiota before and after MTT
Changes in stool microbiota measured by metagenomic analysis.
Measured: Baseline/pre-intervention through Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start10 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two nonrandomized active-treatment cohorts based on baseline urinary chemistry: hyperoxaluric and hypercalciuric. All participants receive the same MTT regimen and serve as their own controls.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua Stern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor-investigator, Joshua Stern, Intermountain Health Care, Inc.
- Investigators
- Joshua Stern, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516472
- Sponsor's protocol ID
- 1051917
- Acronym
- FMT IND
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation (FMT CAPSULE DE, FMPCapDE, MTP-CP101) in Kidney Stone Patients (FMT IND STUDY)
- ClinicalTrials.gov ID
- NCT05516472
- Acronym / sponsor ID
- FMT IND / 1051917
- Conditions
- Kidney Stones, Urinary Stone Disease / Nephrolithiasis, Recurrent Calcium-oxalate Kidney Stones
- Keywords
- microbial transplant therapy, kidney stones
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Joshua SternUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label pilot study evaluates whether oral microbial transplant therapy can change urine factors associated with recurrent calcium-oxalate kidney stones. Adults with high urine calcium or high urine oxalate will receive antibiotic pretreatment followed by microbial capsules. Changes in 24-hour urine calcium and oxalate and treatment safety will be assessed.
Detailed description
Participants with recurrent calcium-oxalate stones are assigned to a hyperoxaluric or hypercalciuric cohort based on baseline 24-hour urine results. All participants receive vancomycin 500 mg twice daily and neomycin 1,000 mg twice daily for 3 days. Forty-eight to 72 hours later, they take 2 microbial transplant therapy capsules daily for 7 days. Urine and stool samples are collected at baseline, after antibiotics, and during follow-up. Participants serve as their own controls. Follow-up includes weekly contacts through Week 5, telephone/record review at Months 2-6, and record review at Months 9 and 12
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two nonrandomized active-treatment cohorts based on baseline urinary chemistry: hyperoxaluric and hypercalciuric. All participants receive the same MTT regimen and serve as their own controls.
| Arm | Type | Receives |
|---|---|---|
| Hyperoxaluric group | Experimental | Drug: Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101), Drug: Vancomycin and neomycin antibiotic pretreatmentParticipants with urinary oxalate >40 mg/day and <80 mg/day receive antibiotic pretreatment followed by MTT, 2 capsules daily for 7 days. |
| Hypercalciuric Group | Experimental | Drug: Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101), Drug: Vancomycin and neomycin antibiotic pretreatmentParticipants with urinary calcium >225 mg/day receive antibiotic pretreatment followed by MTT, 2 capsules daily for 7 days |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older and younger than 70 years.
- Recent urinary stone disease with at least 50% calcium-oxalate composition confirmed by stone analysis.
- 24-hour urinary calcium >225 mg/day or urinary oxalate >40 mg/day.
- Able to provide informed consent.
- Willing to complete safety follow-up, study visits, 24-hour urine collections, and serial stool collections.
Key exclusion criteria (17 listed)
- Three or more NIH-defined metabolic syndrome features.
- Any autoimmune disease or inflammatory bowel disease.
- Major gastrointestinal surgery within 3 months, excluding appendectomy or cholecystectomy; history of total colectomy or bariatric surgery.
- Primary or secondary hyperparathyroidism or PTH outside 15-65 pg/mL.
- Pancreatic enzyme replacement, ongoing dialysis, or eGFR <60.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101)Also: fecal transplantTwo capsules orally once daily for 7 days, beginning 48-72 hours after completion of antibiotic pretreatment. | Drug | Hypercalciuric Group, Hyperoxaluric group |
| Vancomycin and neomycin antibiotic pretreatmentVancomycin 500 mg orally twice daily and neomycin 1,000 mg orally twice daily for 3 days before MTT. | Drug | Hypercalciuric Group, Hyperoxaluric group |
Primary outcome
Change in 24-hour urinary oxalate concentration from baseline
Time frame: Baseline to Weeks 1, 3, and 5
Within-participant change in urinary oxalate concentration measured in 24-hour urine collections.
Change in 24-hour urinary calcium concentration from baseline
Time frame: Baseline to weeks 1, 3, and 5
Within-participant change in urinary calcium concentration measured in 24-hour urine collections.
Proportion of participants with an adverse event
Time frame: Through Day 30 (+/- 3 days) after MTT
Safety assessed as the proportion of participants experiencing an adverse event through the specified follow-up period.
1 secondary outcome
Metagenomic changes in participant microbiota before and after MTT
Time frame: Baseline/pre-intervention through Week 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Stern, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Microbial Transplant Therapy (FMT CAPSULE DE / FMPCapDE / MTP-CP101) and Vancomycin and neomycin antibiotic pretreatment in people with Kidney Stones and Urinary Stone Disease / Nephrolithiasis, run by Joshua Stern at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nic Unsworth ((801) 507-8280, nic.unsworth@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour urinary oxalate concentration from baseline (time frame: Baseline to Weeks 1, 3, and 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.