Fecal Microbiota Transplantation (FMT) in Treatment of Severe and Enduring Anorexia Nervosa

Exclusion Criteria

• •Male or outside of the 18-45 range
• •Previous FMT or microbiome-based products at any time excluding this study
• •Patients with allergies to ingredients Generally Recognized As Safe (GRAS)
• •Patients with a history of severe anaphylactic or anaphylactoid food allergy
• •Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to start of study
• •Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks
• •Concurrent intensive induction chemotherapy, radiation therapy, or biological treatment for active malignancy.
• •Pregnancy or lactation
• •Febrile illness within past month
• •Treatment with another investigational drug within the past month
• •Alcohol or drug dependence either at time of the study or within the last year
• •Active gastrointestinal infection at time of enrollment
• •Any gastrointestinal or potentially intestinal microbiota-related conditions, including: Severe gastroparesis (e.g., gastric pacemaker) and any history of gastrointestinal illness (including but not limited to inflammatory bowel disease, irritable bowel syndrome, celiac disease, any gastrointestinal cancer, etc.)
• •Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy
• •Type 1 or 2 diabetes mellitus
• •Known or suspected toxic megacolon and/or known small bowel ileus
• •History of total colectomy or bariatric surgery
• •Solid organ transplant recipients less than or equal to 90 days posttransplant or on active treatment for rejection
• •If at risk for CMV/EBV associated disease (at investigator's discretion, e.g. immunocompromised), negative IgG testing for cytomegalovirus (CMV) or Epstein-Barr Virus (EBV).
• •Patients who are immunocompromised
• •Unable or unwilling to comply with protocol requirements
• •Expected life expectancy \< 6 months
• •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