Females who are pregnant, lactating, or planning to become pregnant during the study. Female patients of childbearing potential will take a pregnancy test at the intervention visit and will be excluded if pregnant |
Inability (e.g. dysphasia) to or unwilling to swallow capsules |
Known or suspected toxic megacolon and/or small bowel ileus |
Bowel obstruction or other gut motility issues occurring in the last two weeks that are unresolved as noted by the patient or in the EMR. |
Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment not including appendectomy or cholecystectomy. |
History of bariatric or total colectomy surgery |
Current intensive induction chemotherapy, radiation therapy, or biologic treatment for an active malignancy. Patients on maintenance chemotherapy may be enrolled after consultation with the medical monitor. |
Expected life expectancy less than 6 months. |
Patients with severe anaphylactic or anaphylactoid food allergy. |
Solid organ transplant recipients less than or equal to 90 days post-transplant or on active treatment for rejection. |
Neutropenia (≤500 neutrophils/mL) or other severe immunosuppression. Anti-TNF will be permitted. Patients on monoclonal antibodies to B and T cells, glucocorticoids, antimetabolites (azathioprine, 6-mercaptoputine, methotrexate), calcineurin inhibitors (tacrolimus, cyclosporine), and mycophenolate mofetil may only be enrolled after consultation with the medical monitor. |
At risk of cytomegalovirus (CMV) or Epstein Barr virus (EBV) associated disease (negative IgG testing). |
Any other infectious gastrointestinal illness including diarrhea. |
On oral vancomycin or metronidazole. |
Having been taking the currently prescribed antibiotic longer than 72 h. |
On an antibiotic treatment anticipated to exceed 19 days. |
Having received FMT by any route in the 180 days prior to enrollment. |
Any condition that would jeopardize the safety or rights of the patient, would make it unlikely for the patient to complete the study, or would confound the results of the study. |