Effect of Treatment With Butyric Acid in Anorexia Nervosa

Effetto Del Trattamento Con Acido Butirrico Sull'Anoressia Nervosa

This clinical trial aims to evaluate the therapeutic potential of oral butyric acid supplementation in individuals with anorexia nervosa (AN). T The study will assess whether butyric acid, administered alongside standard multidisciplinary care, improves weight restoration and contributes to overall clinical recovery.

The primary objectives are to determine:

- Whether butyric acid enhances weight restoration during the first 3 months of treatment.

Participants will be randomly assigned to receive either butyric acid or a placebo for 3 months, in addition to treatment-as-usual, which includes nutritional rehabilitation and cognitive-behavioral therapy.

Throughout the study, researchers will monitor:

• Changes in body weight and Body Mass Index (BMI)
• General and eating-disorder-related psychopathology
• Blood-based biomarkers related to inflammation, metabolism, and neuroendocrine function
• Gut microbiota composition and metabolites, including short-chain fatty acids

A total of 50 participants with AN are expected to be enrolled.

Inclusion Criteria:

• Female sex
• Age 18-65 years
• Current diagnosis of Anorexia Nervosa (DSM-5)
• Able and willing to provide informed consent
• Ability to comply with study procedures and assessments

Exclusion Criteria:

• Severe psychiatric conditions requiring inpatient hospitalization (e.g., psychosis, severe major depressive episode with suicidal intent)
• Severe medical conditions requiring inpatient care (cardiovascular, renal, hematopoietic, gastrointestinal, endocrine disorders)
• Intellectual disability, illiteracy, or conditions impairing consent or questionnaire completion
• Current participation in another experimental protocol
• Active use of probiotics
• Neutropenia (<0.5 × 10^9/L)
• Leukocytosis (>30 × 10^9/L)
• Fever > 38°C
• Radiological evidence of toxic megacolon or intestinal perforation
• Presence of colostomy
• Severe comorbidity limiting 30-day survival
• Active or past malignancy requiring chemotherapy
• Corticosteroid therapy within the past 6 months
• HIV infection