Fecal Microbiota Transplantation in Females With Anorexia Nervosa

Anorexia Nervosa

Anorexia nervosa, Fecal microbiota transplantation, FMT, Gut microbiome, Gut microbiota, Microbiome, Eating disorders, Gastrointestinal function, Oral FMT, Placebo-controlled trial

The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) can change the gut microbiome and improve health outcomes in females with anorexia nervosa. FMT involves transferring microorganisms from the stool of a carefully screened healthy donor to the intestine of another person. In this study, FMT will be given as capsules that are swallowed by the participants. The main questions the study aims to answer are: * Does repeated treatment with FMT change the gut microbiome in females with anorexia nervosa? * Does FMT improve symptoms and other health outcomes related to anorexia nervosa? * How does FMT affect gastrointestinal function, including bowel habits and gut transit time in females with anorexia nervosa? * What medical problems or side effects do the participants experience during the study? Researchers will compare FMT capsules with placebo capsules to see whether FMT affects the gut microbiome, gastrointestinal function, and symptoms related to anorexia nervosa. Placebo capsules are similar to the FMT capsules but do not contain donor fecal material. Participants will: * Receive five weekly FMT treatments and five weekly placebo treatments * Be randomly assigned to receive either FMT followed by placebo or placebo followed by FMT * Attend four study visits for clinical assessments and follow-up * Provide stool and blood samples at the study visits * Complete questionnaires about eating disorder symptoms, gastrointestinal symptoms, and general health * Provide information about bowel habits and other aspects of gastrointestinal function Neither the participants nor the study staff will know which treatment is being given during each treatment period. The study will include females aged 15 years or older with anorexia nervosa. The study will help researchers better understand the relationship between the gut microbiome and anorexia nervosa and whether changing the gut microbiome with FMT could potentially be a future treatment approach.

Anorexia nervosa (AN) is a severe psychiatric disorder with high morbidity and limited effective treatment options. Emerging evidence suggests persistent gut microbiota (GM) dysbiosis in AN, potentially contributing to gastrointestinal symptoms, appetite dysregulation, and maintenance of the disorder via the gut-brain axis. While preliminary animal studies and human feasibility trials indicate that fecal microbiota transplantation (FMT) can induce biologically relevant GM shifts, no randomized controlled trials have evaluated repeated FMT in patients with AN. Aim: To determine whether repeated oral FMT induces sustained changes in GM composition and improves clinical outcomes in adolescents and adults with AN. Subjects and Methods: AN-SHIFT is a randomized, double-blind, placebo-controlled crossover study enrolling 60-80 female participants aged ≥15 years with AN defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Participants receive five weekly oral FMT treatments and five weekly placebo treatments in alternating sequence. Fecal and blood samples, gut-transit-time, toilet frequency and psychometric assessments are collected at baseline, during intervention, and at 3-month follow-up. The primary outcome is within-subject change in GM composition and donor-strain engraftment assessed by shotgun metagenomic sequencing. Secondary outcomes include, gut-transit-time alterations, eating disorder symptoms, gastrointestinal symptoms, appetite- and mood-related biomarkers, and their associations with GM changes. All participants will during the trial receive FMT either before or after placebo, and standard clinical care continues throughout the study period. Perspectives: This study evaluates a biologically informed, low-risk intervention targeting a potential mechanism to alleviate comorbidities associated with AN in patients with AN. The findings will provide critical evidence on feasibility, safety, and biological efficacy and will inform future microbiome-based treatment strategies.

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