Effetto Del Trattamento Con Acido Butirrico Sull'Anoressia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Weight
时间窗: Baseline and 3 months
Body weight measured in kilograms using a calibrated scale.
Body Mass Index (BMI)
时间窗: Baseline and 3 months
BMI calculated as weight (kg) divided by height (m²). Unit of Measure: kg/m²
Gut Microbiota Composition
时间窗: 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)
时间窗: 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.
次要结局
- Eating disorder psychopatology - Eating Disorder Examination Questionnaire 6.0 (EDE-Q 6.0; Calugi et al., 2015)(Baseline and 3 months)
- Eating disorder psychopathology - Eating Disorder Inventory - 3 (EDI-3; Clausen et al., 2011)(Baseline and 3 months)
- General psychopathology - Brief Symptom Inventory (BSI); Derogatis & Melisaratos, 1983)(Baseline and 3 months)
- Childhood maltreatment - Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein et al., 2003)(Baseline)
- Emotional dysregulation - Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)(Baseline and 3 months)