RECRUITING

MTC Versus FMT in for RCDI

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Conditions

Clostridiodies Difficile Infections

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Investigating four different treatment of MTC or FMT

Official Title

Comparison of MTC01 vs FMT for the Treatment of Recurrent Clostridioides Difficile Infection

Quick Facts

Study Start:2024-01-08
Study Completion:2025-07-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05911997

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages eligible for study: 18 years and older
  2. * Able and willing to provide written informed consent
  3. * History of recurrent CDI defined as 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode)
  4. * Subjects with a qualifying recurrent CDI episode, defined as:
  5. * History of diarrhea (\>=3 unformed stools per day for 2 or more consecutive days that is clinically consistent with CDI
  6. * 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.
  7. * 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)
  8. * Demonstrated adequate clinical response, defined as \<= 3 unformed stools per day for 2 or more consecutive days during SOC CDI antibiotics prior to randomization.
  9. * CDI symptoms started within 60 days prior to randomization.
  1. * Female subjects who are pregnant or breastfeeding or are planning to become pregnant during the study.
  2. * Women with reproductive potential should use a reliable method of birth control:
  3. * 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
  4. * Known or suspected toxic megacolon, ileus or bowel obstruction at the time of enrollment.
  5. * Subjects with active gastroenteritis due to infectious causes other than CDI
  6. * Subjects with allergies to ingredients present in the investigational product
  7. * Prior participation in studies of investigational live biotherapeutic products or FMT within the last 6 months.
  8. * History of active diarrhea associated with inflammatory bowel disease (IBD).
  9. * Major gastrointestinal surgery within the last 3 months before enrollment.
  10. * Use of drugs that alter gut motility.
  11. * History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to enrollment.
  12. * Unable or unwilling to undergo a colonoscopy
  13. * Inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy.
  14. * Anticipated immediate or upcoming surgery within 30 days
  15. * Need for continued non-anti-CDI antibiotic therapy
  16. * History of total proctocolectomy
  17. * Patients who are unable to give informed consent
  18. * Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
  19. * Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
  20. * Life expectancy \< 6 months
  21. * Unable to adhere to protocol requirements
  22. * Patient who have received an FMT in the past year
  23. * 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
  24. * If a patient is heavily immunosuppressed and is negative for CMV or EBV

Contacts and Locations

Study Contact

Sari Feldman, MS
CONTACT
212-824-7669
sari.feldman@mssm.edu

Principal Investigator

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

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08
Study Completion Date2025-07-25

Study Record Updates

Study Start Date2024-01-08
Study Completion Date2025-07-25

Terms related to this study

Additional Relevant MeSH Terms

  • Clostridiodies Difficile Infections