MTC Versus FMT in for RCDI

NCT05911997 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY-23-005631R01DK130337-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Investigating four different treatment of MTC or FMT

Conditions

Clostridiodies Difficile Infections

Outcome Measures

Primary Outcomes (2)

• 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. 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

  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. 1. Mild 2. Moderate 3. Severe 4. Life threatening 5. Death

  up to 24 weeks

Secondary Outcomes (1)

• Percent of patients who develop Clostridioides difficile (C difficile)

  within 8 weeks

Study Arms (4)

High Dose MTC 01

EXPERIMENTAL

High dose MTC 01 is 10 x 11 CFU slurry to be administered via colonoscopy

Drug: MTC 01

Low Dose MTC 01

EXPERIMENTAL

Low Dose MTC 01 is 10 x 10 CFU slurry to be administered via colonoscopy

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

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

Drug: Fecal Microbiota Transplantation (FMT)

Interventions

MTC 01 DRUG

Slurry to be administered via colonoscopy

High Dose MTC 01; Low Dose MTC 01

Fecal Microbiota Transplantation (FMT) DRUG

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

Also known as: Full spectrum FMT from a single donor

High Dose Fecal Microbiota Transplantation (FMT); Low dose Fecal Microbiota Transplantation (FMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Ari Grinspan, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sari Feldman, MS

CONTACT

212-824-7669; sari.feldman@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Four different interventions

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): July 25, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)