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: 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.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Weight — Baseline and 3 months Body weight measured in kilograms using a calibrated scale.
Body Mass Index (BMI) — Baseline and 3 months BMI calculated as weight (kg) divided by height (m²). Unit of Measure: kg/m²
Gut Microbiota Composition — Baseline and 3 months Assessment of the relative abundance of bacterial taxa through sequencing at baseline and 3 months. Changes over time will be evaluated to identify shifts in microbial composition and potential alterations in gut balance relevant to anorexia nervosa.
Short-Chain Fatty Acids (SCFAs) — Baseline and 3 months Measurement of SCFA concentrations (e.g., butyrate, acetate, propionate) at baseline and 3 months. Changes in SCFA levels will be used to evaluate alterations in gut microbial metabolic activity over time.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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