MTC Versus FMT in for RCDI

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