Anorexia Nervosa, Gut Microbiota, Weight Trajectory
Conditions
Keywords
anorexia nervosa, gut microbiota, butyric acid, outcome
Brief 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.
Interventions
DIETARY_SUPPLEMENTDietary 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).
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emotional dysregulation - Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) | 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 |
| Childhood maltreatment - Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein et al., 2003) | 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. |
| Eating disorder psychopatology - Eating Disorder Examination Questionnaire 6.0 (EDE-Q 6.0; Calugi et al., 2015) | 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. |
| Eating disorder psychopathology - Eating Disorder Inventory - 3 (EDI-3; Clausen et al., 2011) | 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. |
| General psychopathology - Brief Symptom Inventory (BSI); Derogatis & Melisaratos, 1983) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Biomarkers (pg/mL) | Baseline and 3 months | Blood-based inflammatory markers measured in pg/mL (e.g., IL-6, TNF-α). Higher values indicate increased inflammatory activation. |
| Metabolic Biomarkers (mg/dL) | 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. |
| C-Reactive Protein (CRP) | Baseline and 3 months | CRP is a blood marker of systemic inflammation measured in mg/L. Higher levels indicate greater inflammatory activation. |
Countries
Italy
Outcome results
None listed