Anorexia Nervosa
Conditions
Interventions
FMT microcapsule intervention group:For six consecutive days, participants will take oral FMT microcapsules, one bottle each morning. On each dosing day, one bottle of capsules will be removed in adva
placebo microcapsule control group:For six consecutive days, participants will take oral placebo microcapsules that are identical in appearance to the FMT microcapsules, at a dose of one bottle each m
Sponsors
Peking University Sixth Hospital
Eligibility
Sex/Gender
Female
Age
13 Years to 17 Years
Inclusion criteria
Inclusion criteria: Participants will be eligible for inclusion only if all of the following criteria are met: 1. Female adolescents aged 13–17 years (inclusive); 2. Meet the diagnostic criteria for anorexia nervosa as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3. Duration of illness = 8 on either the 17-item Hamilton Depression Rating Scale (HAMD-17) or the 14-item Hamilton Anxiety Rating Scale (HAMA-14); 6. The participant and her legal guardian agree to participate and provide written informed consent (with guardian consent and participant assent as applicable).
Exclusion criteria
Exclusion criteria: Participants will be excluded if any of the following criteria are met: 1. Pregnancy or lactation; 2. Presence of malignant tumors or severe systemic disease, or congenital/acquired immunodeficiency; 3. Severe and/or unstable cardiovascular disease, hepatic disease, renal disease, or other serious organ dysfunction; 4. Other psychiatric disorders, including (but not limited to) major depressive disorder, anxiety disorders, bipolar disorder, schizophrenia, etc.; 5. Gastrointestinal conditions associated with severe impairment of the intestinal barrier, such as inflammatory bowel disease, Crohn’s disease, intestinal tuberculosis, ischemic bowel disease, or radiation enteritis; and/or inability to tolerate >= 1000 kcal/day of enteral nutrition; 6. Recent use of antibiotics or probiotics: antibiotic use within the past 1 month, or probiotic use within the past 1 week; 7. Recent treatment with high-risk immunosuppressive or cytotoxic agents, e.g., rituximab, doxorubicin, or prolonged use (>= 4 weeks) of medium- to high-dose systemic corticosteroids (prednisone >= 20 mg/day or equivalent); 8. Absolute neutrophil count (ANC) < 1.5 × 10?/L; 9. Positive test results for infectious pathogens; 10. Any other condition not listed above that, in the investigator’s judgment based on physical examination and/or clinical assessment, may affect study participation, safety, or the validity of study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in height and body weight;Eating Disorder Examination Questionnaire (EDE-Q), Eating Disorders Quality of Life (EDQOL);Eating Attitudes Test (EAT-26);the SCOFF questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD-17);Hamilton Anxiety Rating Scale (HAMA-14);Clinical Global Impression scale (CGI);Changes in gut microbial composition and/or diversity;Changes in serum C-reactive protein (CRP);Gastrointestinal Symptom Rating Scale (GSRS);Hepatic and renal function parameters;Recording of adverse events; | — |
Countries
China
Contacts
Public ContactYang Lei
Peking University Sixth Hospital
Outcome results
None listed