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MTC01 Versus Fecal Microbiota Transplantation for Recurrent C. Difficile Infections

This study is comparing two treatments for people with recurrent Clostridioides difficile infections (CDI), a type of gut infection. The treatments are MTC01 and Fecal Microbiota Transplantation (FMT). FMT involves transferring stool from a healthy donor into your colon during a colonoscopy. This study wants to see how safe each treatment is by tracking any serious side effects or other side effects for up to 24 weeks. You may be able to join if you are 18 or older and have had at least two CDI episodes in the last six months. The current recruitment status is unclear.

Study design
This study is comparing two different treatments and plans to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 weeks after treatment to monitor for side effects.

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NCT05911997

MTC Versus FMT in for RCDI

Recruiting
PHASE1Ages 18+InterventionalPrevention
Icahn School of Medicine at Mount Sinai
~60 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:MTC 01Fecal Microbiota Transplantation (FMT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of treatment-related serious adverse events (SAE) as assessed by NIH grading
Measured over up to 24 weeks
+1 more outcome measured

Conditions

Clostridiodies Difficile Infections

Explore related trials

Clostridium difficile Infection

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Ari Grinspan, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Sari Feldman, MS
[email protected]
212-824-7669
Email the study team

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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
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

What this trial measures

  • Number of treatment-related serious adverse events (SAE) as assessed by NIH gradingup 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 5.0up 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