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NCT Number: NCT07289581

Effect of Treatment With Butyric Acid in Anorexia Nervosa

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anorexia Nervosa Body Weight Body Weight Changes Body-Weight Trajectory Feeding and Eating Disorders Gut Microbiota Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Trajectory

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SODc Psichiatria, Azienda Ospedaliero-Universitaria Careggi

Florence, FI, 50134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Supplement: Butyric Acid

Dietary Supplement

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).

Primary outcomes

  1. Weight

    Time frame: Baseline and 3 months

    Body weight measured in kilograms using a calibrated scale.

  2. Body Mass Index (BMI)

    Time frame: Baseline and 3 months

    BMI calculated as weight (kg) divided by height (m²). Unit of Measure: kg/m²

  3. Gut Microbiota Composition

    Time frame: 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.

  4. Short-Chain Fatty Acids (SCFAs)

    Time frame: 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.

Secondary outcomes

  1. Eating disorder psychopatology - Eating Disorder Examination Questionnaire 6.0 (EDE-Q 6.0; Calugi et al., 2015)

    Time frame: Baseline and 3 months

    The EDE-Q measures eating-disorder psychopathology across four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. Items are scored from 0 to 6. The Global Score is the mean of the four subscales. Higher scores indicate more severe eating-disorder symptoms. Unit of Measure: Units on a scale.

  2. Eating disorder psychopathology - Eating Disorder Inventory - 3 (EDI-3; Clausen et al., 2011)

    Time frame: Baseline and 3 months

    The EDI-3 evaluates psychological traits associated with eating disorders. It includes subscales such as Drive for Thinness, Bulimia, Body Dissatisfaction, Low Self-Esteem, Emotional Dysregulation, Interoceptive Deficits, Perfectionism, Asceticism, and others. Items are typically scored on 0-4 Likert scales. Higher scores indicate greater psychological dysfunction relevant to EDs. Unit of Measure: Units on a scale.

  3. General psychopathology - Brief Symptom Inventory (BSI); Derogatis & Melisaratos, 1983)

    Time frame: Baseline and 3 months

    The BSI assesses general psychopathology. It includes the following subscales: Somatization, Obsessive-Compulsive Symptoms, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Items are rated on a 0-4 scale. Higher scores indicate greater overall psychopathology. Unit of Measure: Units on a scale.

  4. Childhood maltreatment - Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein et al., 2003)

    Time frame: Baseline

    The CTQ-SF assesses exposure to childhood maltreatment. It includes five subscales: Emotional Abuse, Physical Abuse, Sexual Abuse, Emotional Neglect, and Physical Neglect. Subscale scores range from 5 to 25; the total score ranges from 25 to 125. Higher scores indicate more severe childhood maltreatment. Unit of Measure: Units on a scale.

  5. Emotional dysregulation - Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)

    Time frame: Baseline and 3 months

    The DERS measures emotion-regulation difficulties. It includes six subscales: Nonacceptance, Goals, Impulse, Awareness, Strategies, and Clarity. Total scores range from 36 to 180. Higher scores indicate greater difficulties in emotion regulation. Unit of Measure: Units on a scale

Other outcomes

  1. Inflammatory Biomarkers (pg/mL)

    Time frame: Baseline and 3 months

    Blood-based inflammatory markers measured in pg/mL (e.g., IL-6, TNF-α). Higher values indicate increased inflammatory activation.

  2. C-Reactive Protein (CRP)

    Time frame: Baseline and 3 months

    CRP is a blood marker of systemic inflammation measured in mg/L. Higher levels indicate greater inflammatory activation.

  3. Metabolic Biomarkers (mg/dL)

    Time frame: Baseline and 3 months

    Metabolic markers measured in mg/dL, including glucose and lipid profile components. Variations may reflect changes in metabolic functioning and nutritional status.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study title

Effetto Del Trattamento Con Acido Butirrico Sull'Anoressia Nervosa

Acronym: AN-BUTIX

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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