Fecal Microbiota Transplant for Anorexia Nervosa

In the following pilot randomized-controlled trial, the investigators' aim is to determine whether FMT treatment demonstrates feasibility, acceptability, and preliminary effectiveness in pediatric AN participants. The investigators will assess how the use of FMT affects participants' rate of weight restoration, gut microbiome, relevant urine and blood biomarkers, and mood symptoms. The investigators' rationale for performing the study is to better understand the interactions between the intestinal microbiome, energy regulation, and behavior. This will be the first study to assess the role of FMT in pediatric AN and will help establish whether this adjunctive treatment modality has benefit in managing the metabolic and behavioral manifestations of this complex neuropsychiatric disorder.

In terms of study procedures, members of a pilot sample of 20 AN patients recruited from McMaster Children's Hospital will be randomized to receive FMT or placebo. All participants will be asked to complete a battery of assessments at regular intervals over the 8-week intervention period, and at a follow-up point at four weeks post-intervention.

The study's primary outcomes are recruitment and retention rates. Descriptive statistics will be used to determine the number of adolescents who will agree to participate in the study and those who will complete the study.

One of the study's secondary outcomes is participants' attitudes toward FMT. This will be measured through qualitative interviews among those who completed the intervention and those who do not agree to participate in the study.

The investigators will know we have reached saturation by using a method called "information power" and will explore how broad the research questions are, if there are clear theories to guide the analysis, how varied the participants in the study are, and how much useful information is accrued. Based on this, the investigators will determine the appropriate number of interviews to lead.

The remaining secondary outcome is a battery of preliminary outcomes (clinical, biological, biochemical and safety). The investigators will assess these outcomes at multiple timepoints using questionnaires, anthropometric data, stool analysis (16s rRNA), urine metabolic analysis, saliva ultra filtrates, changes in blood work, and common terminology criteria for adverse events for safety outcomes.

• Attitudes towards Fecal Microbiota Transplant [Срок оценки: Week 12 (follow-up)]
• Height [Срок оценки: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
• Weight [Срок оценки: Week 0 (baseline), Week 2, Week 4 (mid-treatment), Week 6, Week 8 (post-intervention), Week 10, Week 12 (follow-up)]
• Eating Disorder Examination Questionnaire [Срок оценки: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
• Beck Depression Inventory [Срок оценки: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
• Beck Anxiety Inventory [Срок оценки: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
• Yale-Brown-Cornell Eating Disorder Scale [Срок оценки: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
• Gastrointestinal Symptom Rating Scale [Срок оценки: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
• Changes in stool metabolites [Срок оценки: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
• Changes in urine metabolomics [Срок оценки: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
• Changes in saliva ultrafiltrates [Срок оценки: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
• Changes in complete blood count [Срок оценки: Week 0 (baseline), Week 8 (post-intervention)]