PMT for MDRO Decolonization

Exclusion Criteria

• •1. Evidence of colon/small bowel perforation at the time of study screening.
• •2. Unable to tolerate enteral and enema nutrition and medication administration (i.e., only able to tolerate intravenous nutrition and medications).
• •3. Goals of care are directed to comfort rather than curative measures.
• •4. Moderate or severe neutropenia within 10 calendar days prior to enrollment.
• •5. Known food allergy that could lead to anaphylaxis.
• •6. Known allergy to fecal microbiota transplant products or their components
• •7. Pregnancy or lactation
• •1. For subjects of childbearing potential (ages 18 to 55) and who are randomized to receive the intervention, the subject must have a negative pregnancy test within 24 hours prior to product administration
• •2. Female or male subjects (ages 18 to 55) of reproductive potential engaged in active sexual activity that could lead to a pregnancy must agree to use one of the following forms of birth control while receiving study medications and through day 28 following completion of treatment, at minimum:
• •i. Male or female condoms
• •ii. Diaphragm or cervical cap with spermicide, if available
• •iii. Intrauterine device (IUD)
• •iv. Oral contraceptives or other hormonal contraception
• •8. Known gastrointestinal disease that could affect the safety of fecal microbiota transplant at time of enrollment:
• •1. Inflammatory Bowel Disease (IBD)
• •2. Short Gut Syndrome
• •3. Fistulas
• •4. Bowel resection surgery
• •5. Colitis