Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children

Prior treatment

• Severe immunosuppression: concomitant steroids (1mg/kg/day or greater than 30 mg/day) and biologicals like infliximab, Adalimumab, Golimumab, Certolizuman, Ustekinemab.
• On antibiotics with the inability to discontinue within 4 weeks prior to FMT procedure.
• Participation in an investigational drug study within 30 days of screening.
• Change in therapy within the previous 30 days.
• Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy. Patients on maintenance chemotherapy may be enrolled only after consultation with medical monitor
• Previous usage of FMT products within 1 year of enrollment excluding this study.
• Solid organ transplant recipients 90 days post-transplant or on active treatment for rejection.

Other illness

• Patients found to have complications such as an abscess, phlegmon, stricture, small bowel obstruction, perforation, internal or external fistulation or infection as causes for flare up.
• Worsening Inflammatory Bowel disease between time of consenting and FMT resulting in PCDAI greater than 40, or are unable to wait for the routine procedure due to rapid deterioration.
• A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study
• Active or gastrointestinal infection at time of enrollment.
• Patients with a history of severe anaphylactic or anaphylactoid food allergy.
• If at risk for CMV associated disease (at investigator's discretion, e.g. immunocompromised), negative IgG testing for cytomegalovirus (CMV).
• Stool infections including C.Diff (checked at the study center for consistency). If positive for C.Diff, they can be eligible if symptoms persist despite successful treatment and negative stool test obtained 1 month after discontinuation of antibiotics.

Lab values

• Neutropenia (500 neutrophils/mL) or other severe immunosuppression. Anti-TNF will be permitted. Patients on monoclonal antibodies to B and T cells, calcineurin inhibitors (tacrolimus, cyclosporine) and mycophenolate mofetil may be enrolled only after consultation with the medical monitor.

Age

• Female patients of childbearing age who are pregnant, lactating, or plan to become pregnant during study.

Other

• Established central line or planned placement during trial.
• Pressor or ventilator support.
• Requires continued antibiotic use or anticipates antibiotic use in upcoming 4 weeks.
• Not willing or able to consent or follow guidelines throughout research trial.
• Non-English Speaking
• Known or suspected toxic megacolon
• Admitted to or expected to an intensive care unit for medical reasons (not just boarding).
• Expected life expectancy less than 6 months
• Severe anal fissues.

• Male or female subjects between the age of 2 and 25 years.
• Current CD patients who have either:
  • o CD with mild to moderately active disease (PCDAI 10-37.5) due to failure of current therapy that has been stable for 4 weeks and are undergoing colonoscopy. For this study we will recruit only those CD patients who have disease only in colon or colon and terminal ileum so disease can be accurately assessed prior to and after FMT.
• The ability to safely undergo colonoscopy (physical status classification of one through three used by the American Society of Anesthesiologists, see Appendix A) as determined by Principal Investigator.
• Females of childbearing potential must have a negative urine pregnancy test during screening and a negative urine pregnancy test at visit 2 (FMT procedure day).
• Informed consent and assent (per IRB/EC), as appropriate.
• Subject must be willing to comply with all study related procedures, follow up visits and complete home diaries.