Clinical Trial

Effect of Treatment With Butyric Acid in Anorexia Nervosa

Study acronym: AN-BUTIX
Active, Not Recruiting
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Summary
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.
Trial Details
NCT Number NCT07289581
Lead Sponsor Azienda Ospedaliero-Universitaria Careggi
Conditions Anorexia Nervosa, Gut Microbiota, Weight Trajectory
Enrollment 50 participants
Start Date 2025-11-12
Primary Completion 2026-11-12 (estimated)
Study Completion 2028-11-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-17