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
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.
Show all 9Show fewer
- 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
Show all 24Show fewer
- 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