MTC Versus FMT in for RCDI

Recruiting now · Phase 1

Conditions studied: Clostridiodies Difficile Infections

In brief

Investigating four different treatment of MTC or FMT

Key facts

Study ID

NCT05911997

Run by

Icahn School of Medicine at Mount Sinai

People needed

60

Starts

2024-01-08

Expected to finish

2026-07-25

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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