MTC Versus FMT in for RCDI
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: January 08, 2024
End Date: July 25, 2026
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