Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 29252 | Registry Identifier | Comitato Etico Area Vasta Centro - CEAVC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
A total of 50 participants with AN are expected to be enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: Butyric Acid | Active Comparator | Participants with anorexia nervosa receiving butyric acid supplementation plus Treatment As Usual. |
|
| Placebo Comparator: Placebo | Placebo Comparator | Participants with anorexia nervosa receiving placebo capsules plus Treatment As Usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Body weight measured in kilograms using a calibrated scale. | Baseline and 3 months |
| Body Mass Index (BMI) | BMI calculated as weight (kg) divided by height (m²). Unit of Measure: kg/m² | Baseline and 3 months |
| Gut Microbiota Composition | 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. | Baseline and 3 months |
| Short-Chain Fatty Acids (SCFAs) | 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. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Eating disorder psychopatology - Eating Disorder Examination Questionnaire 6.0 (EDE-Q 6.0; Calugi et al., 2015) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Biomarkers (pg/mL) | Blood-based inflammatory markers measured in pg/mL (e.g., IL-6, TNF-α). Higher values indicate increased inflammatory activation. | Baseline and 3 months |
| C-Reactive Protein (CRP) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Castellini, Medical Degree | Department of Health Sciences, University of Florence, Florence, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SODc Psichiatria, Azienda Ospedaliero-Universitaria Careggi | Florence | FI | 50134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37884972 | Background | Quagebeur R, Dalile B, Raes J, Van Oudenhove L, Verbeke K, Vrieze E. The role of short-chain fatty acids (SCFAs) in regulating stress responses, eating behavior, and nutritional state in anorexia nervosa: protocol for a randomized controlled trial. J Eat Disord. 2023 Oct 26;11(1):191. doi: 10.1186/s40337-023-00917-6. | |
| 27229737 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D000077962 | Body-Weight Trajectory |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dietary Supplement: Butyric Acid | Dietary Supplement | 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. |
|
| Baseline and 3 months |
| Eating disorder psychopathology - Eating Disorder Inventory - 3 (EDI-3; Clausen et al., 2011) | 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. | Baseline and 3 months |
| General psychopathology - Brief Symptom Inventory (BSI); Derogatis & Melisaratos, 1983) | 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. | Baseline and 3 months |
| Childhood maltreatment - Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein et al., 2003) | 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. | Baseline |
| Emotional dysregulation - Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) | 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 | Baseline and 3 months |
CRP is a blood marker of systemic inflammation measured in mg/L. Higher levels indicate greater inflammatory activation.
| Baseline and 3 months |
| Metabolic Biomarkers (mg/dL) | Metabolic markers measured in mg/dL, including glucose and lipid profile components. Variations may reflect changes in metabolic functioning and nutritional status. | Baseline and 3 months |
| Mack I, Cuntz U, Gramer C, Niedermaier S, Pohl C, Schwiertz A, Zimmermann K, Zipfel S, Enck P, Penders J. Weight gain in anorexia nervosa does not ameliorate the faecal microbiota, branched chain fatty acid profiles, and gastrointestinal complaints. Sci Rep. 2016 May 27;6:26752. doi: 10.1038/srep26752. |
| 31504398 | Background | Hata T, Miyata N, Takakura S, Yoshihara K, Asano Y, Kimura-Todani T, Yamashita M, Zhang XT, Watanabe N, Mikami K, Koga Y, Sudo N. The Gut Microbiome Derived From Anorexia Nervosa Patients Impairs Weight Gain and Behavioral Performance in Female Mice. Endocrinology. 2019 Oct 1;160(10):2441-2452. doi: 10.1210/en.2019-00408. |
| 32476236 | Result | Facchin S, Vitulo N, Calgaro M, Buda A, Romualdi C, Pohl D, Perini B, Lorenzon G, Marinelli C, D'Inca R, Sturniolo GC, Savarino EV. Microbiota changes induced by microencapsulated sodium butyrate in patients with inflammatory bowel disease. Neurogastroenterol Motil. 2020 Oct;32(10):e13914. doi: 10.1111/nmo.13914. Epub 2020 May 31. |
| 37474544 | Result | Castellini G, Cassioli E, Vitali F, Rossi E, Dani C, Melani G, Flaccomio D, D'Andria M, Mejia Monroy M, Galli A, Cavalieri D, Ricca V, Bartolucci GL, De Filippo C. Gut microbiota metabolites mediate the interplay between childhood maltreatment and psychopathology in patients with eating disorders. Sci Rep. 2023 Jul 20;13(1):11753. doi: 10.1038/s41598-023-38665-x. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |