Clostridiodies Difficile InfectionsPhase 1NCT05911997
MTC Versus FMT in for RCDI
A Phase 1 study testing MTC 01 and Fecal Microbiota Transplantation (FMT) in people with Clostridiodies Difficile Infections, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Investigating four different treatment of MTC or FMT Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridiodies Difficile Infections
- What is being tested?
- MTC 01 and Fecal Microbiota Transplantation (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 3 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages eligible for study: 18 years and older
- Able and willing to provide written informed consent
- History of recurrent CDI defined as 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode)
- Subjects with a qualifying recurrent CDI episode, defined as:
- History of diarrhea (>=3 unformed stools per day for 2 or more consecutive days that is clinically consistent with CDI
- Documented positive stool test by local laboratory for toxigenic C. difficile (toxin EIA or PCR-based testing) for the current CDI episode within 60 days prior to randomization.
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- Received a course of standard-of-care (SOC) CDI antibiotics for the most recent CDI episode (for 10 to 42 days, with exact duration, antibiotic type and dose at the discretion of the Investigator)
- Demonstrated adequate clinical response, defined as <= 3 unformed stools per day for 2 or more consecutive days during SOC CDI antibiotics prior to randomization.
- CDI symptoms started within 60 days prior to randomization.
Who cannot join
- Female subjects who are pregnant or breastfeeding or are planning to become pregnant during the study.
- Women with reproductive potential should use a reliable method of birth control:
- Consistent use of an approved hormonal contraception (birth control pill/patches, rings); An intrauterine device (IUD); Contraceptive injection (Depo-Provera); Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam); Sexual abstinence (no sexual intercourse) or Sterilization
- Known or suspected toxic megacolon, ileus or bowel obstruction at the time of enrollment.
- Subjects with active gastroenteritis due to infectious causes other than CDI
- Subjects with allergies to ingredients present in the investigational product
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- Prior participation in studies of investigational live biotherapeutic products or FMT within the last 6 months.
- Major gastrointestinal surgery within the last 3 months before enrollment.
- Use of drugs that alter gut motility.
- History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to enrollment.
- Unable or unwilling to undergo a colonoscopy
- Inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy.
- Anticipated immediate or upcoming surgery within 30 days
- Need for continued non-anti-CDI antibiotic therapy
- History of total proctocolectomy
- Patients who are unable to give informed consent
- Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
- Life expectancy < 6 months
- Unable to adhere to protocol requirements
- Patient who have received an FMT in the past year
- Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT
- Clinically significant abnormal lab values including but not limited to WBC >15 x 103/mm3, ANC <0.5 x 103/mm3, or laboratory evidence of acute kidney injury at Investigator's discretion, at screening
- If a patient is heavily immunosuppressed and is negative for CMV or EBV
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Comparison of MTC01 vs FMT for the Treatment of Recurrent Clostridioides Difficile Infection
Investigating four different treatment of MTC or FMT
Read the detailed description
The purpose of this research study is to compare two different treatments for patients with recurrent Clostridiodies difficile infections: MTC01 vs fecal microbiota transplantation (FMT). FMT is the transfer of bacteria from a healthy donor's colon to a recipient's colon. To do this, stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy. This treatment is now considered standard medical care for recurrent Clostridioides difficile infections.
One FMT dose contains the entire collection of microbes in a healthy donor and is made up of billions of microbes. Each dose of FMT is different from the next and it is unknown exactly what microbes are present in each dose.
- Conditions
- Clostridiodies Difficile Infections
- Being tested
- MTC 01, Fecal Microbiota Transplantation (FMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTC 01Drug
Slurry to be administered via colonoscopy
Fecal Microbiota Transplantation (FMT)Drug
Also called Full spectrum FMT from a single donor
Stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| High Dose MTC 01 | Experimental | High dose MTC 01 is 10 x 11 CFU slurry to be administered via colonoscopy Receives: Drug: MTC 01 |
| Low Dose MTC 01 | Experimental | Low Dose MTC 01 is 10 x 10 CFU slurry to be administered via colonoscopy Receives: Drug: MTC 01 |
| Low dose Fecal Microbiota Transplantation (FMT) | Active comparator | High dose FMT is 10 x 11 CFU slurry to be administered via colonoscopy Receives: Drug: Fecal Microbiota Transplantation (FMT) |
| High Dose Fecal Microbiota Transplantation (FMT) | Experimental | Low dose FMT is 10 x 10 CFU slurry to be administered via colonoscopy Receives: Drug: Fecal Microbiota Transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-related serious adverse events (SAE) as assessed by NIH grading
Number of serious adverse events per NIH grading indications. Grade 1-5, where grade 3-5 are considered severe.
- Mild
- Moderate
- Severe
- Life threatening
- Death Serious Adverse Event (SAE):
Any adverse event that:
- Results in death
- Is life threatening, or places the participant at immediate risk of death from the event as it occurred
- Requires or prolongs hospitalization
- Causes persistent or significant disability or incapacity
- Results in congenital anomalies or birth defects
- Is another condition which investigators judge to represent significant hazards
Measured: up to 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0, grade 1-2, where higher grades indicate higher levels of impairment.
- Mild
- Moderate
- Severe
- Life threatening
- Death
Measured: up to 24 weeks
Secondary outcomes (1)
Percent of patients who develop Clostridioides difficile (C difficile)
Recurrence of Clostridioides difficile (C difficile) within 8 weeks of receiving treatment. The stool C difficile toxin test detects harmful substances produced by the C difficile bacterium . This infection is a common cause of diarrhea after antibiotic use. Abnormal results mean that toxins produced by C difficile are seen in the stool and are causing diarrhea.
Measured: within 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start8 Jan 2024
- Primary completion13 Nov 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridiodies Difficile InfectionsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four different interventions
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ari M Grinspan, Icahn School of Medicine at Mount Sinai
- Investigators
- Ari Grinspan, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911997
- Sponsor's protocol ID
- STUDY-23-00563
- Other IDs
- 1R01DK130337-01A1
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will not be shared with patients. However aggregate data will be shared with the NIH and for publications. The DSMB is within mount Sinai.
Publications
Bethlehem L, Bartu L, Marke G, Mar P, Feldman S, Eggers J, Ruprecht C, Britton GJ, Aggarwala V, Bongers G, Li Z, Yang N, Hohmann EL, Mogno I, Faith JJ, Grinspan A. 15-strain live biotherapeutic product or same donor fecal microbiota transplant for recurrent Clostridioides difficile infection: a randomized phase 1b trial. Nat Med. 2026 Jul;32(7):2546-2555. doi: 10.1038/s41591-026-04442-2. Epub 2026 Jun 2.
PubMed 42230754
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of MTC01 vs FMT for the Treatment of Recurrent Clostridioides Difficile Infection
- ClinicalTrials.gov ID
- NCT05911997
- Acronym / sponsor ID
- STUDY-23-00563
- Conditions
- Clostridiodies Difficile Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 22 Jun 2023 (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.
Investigating four different treatment of MTC or FMT
Detailed description
The purpose of this research study is to compare two different treatments for patients with recurrent Clostridiodies difficile infections: MTC01 vs fecal microbiota transplantation (FMT). FMT is the transfer of bacteria from a healthy donor's colon to a recipient's colon. To do this, stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy. This treatment is now considered standard medical care for recurrent Clostridioides difficile infections.
One FMT dose contains the entire collection of microbes in a healthy donor and is made up of billions of microbes. Each dose of FMT is different from the next and it is unknown exactly what microbes are present in each dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four different interventions
| Arm | Type | Receives |
|---|---|---|
| High Dose MTC 01 | Experimental | Drug: MTC 01High dose MTC 01 is 10 x 11 CFU slurry to be administered via colonoscopy |
| Low Dose MTC 01 | Experimental | Drug: MTC 01Low Dose MTC 01 is 10 x 10 CFU slurry to be administered via colonoscopy |
| Low dose Fecal Microbiota Transplantation (FMT) | Active comparator | Drug: Fecal Microbiota Transplantation (FMT)High dose FMT is 10 x 11 CFU slurry to be administered via colonoscopy |
| High Dose Fecal Microbiota Transplantation (FMT) | Experimental | Drug: Fecal Microbiota Transplantation (FMT)Low dose FMT is 10 x 10 CFU slurry to be administered via colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages eligible for study: 18 years and older
- Able and willing to provide written informed consent
- History of recurrent CDI defined as 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode)
- Subjects with a qualifying recurrent CDI episode, defined as:
- CDI symptoms started within 60 days prior to randomization.
Key exclusion criteria (24 listed)
- Female subjects who are pregnant or breastfeeding or are planning to become pregnant during the study.
- Women with reproductive potential should use a reliable method of birth control:
- Known or suspected toxic megacolon, ileus or bowel obstruction at the time of enrollment.
- Subjects with active gastroenteritis due to infectious causes other than CDI
- Subjects with allergies to ingredients present in the investigational product
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 |
|---|---|---|
| MTC 01Slurry to be administered via colonoscopy | Drug | High Dose MTC 01, Low Dose MTC 01 |
| Fecal Microbiota Transplantation (FMT)Also: Full spectrum FMT from a single donorStool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy | Drug | High Dose Fecal Microbiota Transplantation (FMT), Low dose Fecal Microbiota Transplantation (FMT) |
Primary outcome
Number of treatment-related serious adverse events (SAE) as assessed by NIH grading
Time frame: up to 24 weeks
Number of serious adverse events per NIH grading indications. Grade 1-5, where grade 3-5 are considered severe. 1. Mild 2. Moderate 3. Severe 4. Life threatening 5. Death Serious Adverse Event (SAE): Any adverse event that: * Results in death * Is life threatening, or places the participant at immediate risk of death from the event as it occurred * Requires or prolongs hospitalization * Causes persistent or significant disability or incapacity * Results in congenital anomalies or birth defects * Is another condition which investigators judge to represent significant hazards
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Time frame: up to 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0, grade 1-2, where higher grades indicate higher levels of impairment. 1. Mild 2. Moderate 3. Severe 4. Life threatening 5. Death
1 secondary outcome
Percent of patients who develop Clostridioides difficile (C difficile)
Time frame: within 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 42230754Bethlehem L, Bartu L, Marke G, Mar P, Feldman S, Eggers J, Ruprecht C, Britton GJ, Aggarwala V, Bongers G, Li Z, Yang N, Hohmann EL, Mogno I, Faith JJ, Grinspan A. 15-strain live biotherapeutic product or same donor fecal microbiota transplant for recurrent Clostridioides difficile infection: a randomized phase 1b trial. Nat Med. 2026 Jul;32(7):2546-2555. doi: 10.1038/s41591-026-04442-2. Epub 2026 Jun 2.
- Individual participant dataSharing planned: Yes. Data will not be shared with patients. However aggregate data will be shared with the NIH and for publications. The DSMB is within mount Sinai.
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. This study is not recruiting at the moment.
Ari Grinspan, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTC 01 and Fecal Microbiota Transplantation (FMT) in people with Clostridiodies Difficile Infections, run by Icahn School of Medicine at Mount Sinai 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 9 inclusion and 24 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: finished, as of the sponsor's last update on 3 Sep 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-related serious adverse events (SAE) as assessed by NIH grading (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911997, which also lists 1 linked publication.
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 3 Sep 2026.