Comparing MTC and FMT treatments for recurrent Clostridioides difficile infections
Comparison of MTC01 vs FMT for the Treatment of Recurrent Clostridioides Difficile Infection
This study tests whether a new treatment called MTC01 works better than the standard stool transplant for people with recurring Clostridioides difficile infections.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05911997 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of two treatments for patients suffering from recurrent Clostridioides difficile infections: MTC01 and fecal microbiota transplantation (FMT). FMT involves transferring healthy bacteria from a donor's stool into the recipient's colon via colonoscopy, which is currently a standard treatment for this condition. The study aims to determine how MTC01 compares to FMT in treating these infections. Participants will be monitored for their response to these treatments over the course of the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of recurrent Clostridioides difficile infections.
Not a fit: Patients who do not have recurrent Clostridioides difficile infections or those who are not eligible based on the study's inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an alternative treatment option for patients with recurrent Clostridioides difficile infections.
How similar studies have performed: Previous studies have shown success with fecal microbiota transplantation for recurrent Clostridioides difficile infections, making this approach well-tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ari Grinspan, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Sari Feldman, MS
- Email: sari.feldman@mssm.edu
- Phone: 212-824-7669
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.