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

Ki vehet részt

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Female aged 18-45
• Diagnosed with SE-AN, defined here as having suffered from AN for five or more years and having participated in two or more inpatient or residential treatment programs followed by weight relapse
• Sufficiently medically stable to receive FMT (serum electrolytes within normal limits, normal EKG)
• Willing to adhere to the FMT dosing regimen
• For females of reproductive potential, in sexual relationships with men, must use an acceptable method of contraception from 30 days prior to enrollment until 4 weeks after completing study treatment.* Participants must also be willing to be subjected to periodic pregnancy tests
• Agreement to adhere to Lifestyle Considerations throughout study duration
• Adequate insurance to cover inpatient stay; Lifestyle Considerations: During this study, participants are asked to:; Participate in standard inpatient treatment at UNC-Chapel Hill's CEED; Remain nil per os (npo) on the morning of each dosing session and for two hours after receiving FMT, on four individual instances of FMT administration; Abstain from sexual activity or use a condom or other form of highly effective birth control during the 30-day active stage of the clinical trial; Inform the research team as soon as possible if they become pregnant during the eight-week and six-month follow-up periods; If a trial participant has begun a course of one of this trial's prohibited medications during the eight-week or six-month follow-up periods, participants will be asked only to report the name of the medication, dose, and duration of treatment

Ki nem vehet részt

• Previous FMT or microbiome-based products at any time excluding this study
• 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
• Concurrent intensive induction chemotherapy, radiation therapy, or biological treatment for active malignancy
• Treatment with another investigational drug within the past month
• Alcohol or drug dependence either at time of the study or within the last year
• Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy
• Solid organ transplant recipients less than or equal to 90 days posttransplant or on active treatment for rejection
• Patients with allergies to ingredients Generally Recognized As Safe (GRAS)
• Patients with a history of severe anaphylactic or anaphylactoid food allergy
• Febrile illness within past month
• 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.)
• Type 1 or 2 diabetes mellitus
• History of total colectomy or bariatric surgery
• 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)
• 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
• Male or outside of the 18-45 range
• Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks
• Pregnancy or lactation
• Known or suspected toxic megacolon and/or known small bowel ileus
• Patients who are immunocompromised
• Unable or unwilling to comply with protocol requirements
• Expected life expectancy < 6 months