Standardized Microbiota Transplant Therapy in Crohn's Disease

Inclusion Criteria:

• 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 ofrandomization.

• Any ongoing CD therapy (apart from steroid use) must be at stable doses for 4 weeksprior 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 isencouraged.

• 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 bestopped on a case-by-case basis on discussion with the participant and treatingprovider.

• Women who are not post-menopausal (at least 12 months of non-therapy inducedamenorrhea) or surgically sterile (e.g., absence of ovaries and/or uterus) mustremain abstinent or use a highly effective form of birth control (e.g., oralcontraception, 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.

Exclusion Criteria:

• Extensive bowel resection: i.e., subtotal colectomy or substantial removal of smallbowel where short bowel syndrome could be a concern.

• Documented gastroparesis

• History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.

• 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 opinionof the investigator.

• Presence of ileostomy or colostomy.

• Entero-vesicular fistula (i.e., fistula from bowel to bladder).

• Suspicion of ischemic colitis, radiation colitis or microscopic colitis.

• Diagnosis of ulcerative colitis.

• Active or untreated infection.

• 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.

• History of anaphylactic food allergies.

• End stage liver disease or cirrhosis.

• Anticipated need for antibiotics over the study period.

• Anticipated surgical procedure over the study period.

• An absolute neutrophil count <500 cell/µL.

• Diagnosis of a primary immunodeficiency.

• Active malignancy requiring the use of chemotherapeutic agent (except for localizednon-melanomatous skin cancers).

• Patients receiving active cytotoxic therapy for solid tumors and hematologicmalignancies.

• Any solid organ transplant within 6 months of randomization.

• Use of chimeric antigen receptor T-cell therapy or hematopoietic cell transplantwithin the past 12 months

• Life expectancy >=6 months.