Effect of Treatment With Butyric Acid in Anorexia Nervosa (AN-BUTIX)

Azienda Ospedaliero-Universitaria Careggi

Status: Active, not recruiting

Conditions: Gut Microbiota; Weight Trajectory; Anorexia Nervosa

Treatments: Dietary Supplement: Dietary Supplement: Butyric Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT07289581

29252 (Registry Identifier)

29252_spe

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Active Comparator: Butyric Acid

Active Comparator group

Description:

Participants with anorexia nervosa receiving butyric acid supplementation plus Treatment As Usual.

Treatment:

Dietary Supplement: Dietary Supplement: Butyric Acid

Dietary Supplement: Dietary Supplement: Butyric Acid

Placebo Comparator: Placebo

Placebo Comparator group

Description:

Participants with anorexia nervosa receiving placebo capsules plus Treatment As Usual.

Treatment:

Dietary Supplement: Dietary Supplement: Butyric Acid

Dietary Supplement: Dietary Supplement: Butyric Acid