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ACTIVE NOT RECRUITING
NCT07289581
NA

Effect of Treatment With Butyric Acid in Anorexia Nervosa

Sponsor: Azienda Ospedaliero-Universitaria Careggi

View on ClinicalTrials.gov

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.

Official title: Effetto Del Trattamento Con Acido Butirrico Sull'Anoressia Nervosa

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-11-12

Completion Date

2028-11-12

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

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.

Locations (1)

SODc Psichiatria, Azienda Ospedaliero-Universitaria Careggi

Florence, FI, Italy