NCT07289581

Effect of Treatment With Butyric Acid in Anorexia Nervosa

Effetto Del Trattamento Con Acido Butirrico Sull'Anoressia Nervosa

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anorexia Nervosa
• Gut Microbiota
• Weight Trajectory

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Supplement: Butyric Acid	Daily oral supplementation with 2 capsules of microencapsulated butyric acid (Butyrose®, 550 mg each; total daily dose 1,100 mg) for 3 months, administered in addition to Treatment As Usual (nutritional rehabilitation + cognitive-behavioral therapy).
DIETARY_SUPPLEMENT	Dietary Supplement: Butyric Acid	Daily oral supplementation with 2 placebo capsules matched in appearance and composition (maltodextrins, cellulose, inert excipients), administered for 3 months in addition to Treatment As Usual.

Timeline

• Start date: 2025-11-12
• Primary completion: 2026-11-12
• Completion: 2028-11-12
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: Italy