Standardized Microbiota Transplant Therapy in Crohn's Disease

Prior treatment

• Suspicion of ischemic colitis, radiation colitis or microscopic colitis.
• Anticipated surgical procedure over the study period.
• Patients receiving active cytotoxic therapy for solid tumors and hematologic malignancies.
• Any solid organ transplant within 6 months of randomization.
• Use of chimeric antigen receptor T-cell therapy or hematopoietic cell transplant within the past 12 months

Other illness

• Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern.
• History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.
• Entero-vesicular fistula (i.e., fistula from bowel to bladder).
• Active or untreated infection.
• History of anaphylactic food allergies.
• End stage liver disease or cirrhosis.
• Active malignancy requiring the use of chemotherapeutic agent (except for localized non-melanomatous skin cancers).

Lab values

• An absolute neutrophil count \<500 cell/µL.

Other

• Documented gastroparesis
• Symptomatic stricture defined as a stricture that:
  • Cannot be traversed by the colonoscope,
  • Requires intervention to be traversed,
  • Is otherwise responsible for the predominant clinical picture, in the opinion of the investigator.
• Presence of ileostomy or colostomy.
• Diagnosis of ulcerative colitis.
• Adenomatous polyps that have not been removed.
• Use of antibiotics within 14-days of randomization.
• Current pregnancy.
• Current breastfeeding or planning to breastfeed over the study period.
• Anticipated need for antibiotics over the study period.
• Diagnosis of a primary immunodeficiency.
• Life expectancy \<=6 months.

• Able and willing to provide informed consent.
• 18-89 years of age.
• English speaking.
• Diagnosis of CD based on typical clinical and histologic features.
• Active disease on endoscopy:
  • SES-CD \>= 6
  • SES-CD \>= 4 for isolated ileal disease
• Current CD therapies are in the maintenance phase of dosing at the time of randomization.
• Any ongoing CD therapy (apart from steroid use) must be at stable doses for 4 weeks prior to randomization and remain stable over study course.
• Steroid use 20mg or less by 5 days prior to randomization.
• Steroid use stipulations:
• Prednisone must be tapered below 20mg after 7 days.
• Any use of budesonide over the study period is allowed although tapering is encouraged.
• Rescue medications: Steroid courses (up to 40mg for two weeks with a planned taper) are allowed at the discretion of the treating provider. Study drug therapy will be stopped on a case-by-case basis on discussion with the participant and treating provider.
• Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g., absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device).
  • o Periodic abstinence and early withdraw are not acceptable methods.
• Able to comply with study measures in the opinion of the investigator.