Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Eating Disorder
研究概览
简要总结
The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).
详细描述
This is a monocentric study aims to characterise the intestinal microbiota of anorexia nervosa patients with malnutrition, in comparison with the control subject, by DNA sequencing and metagenomic method. The interaction of intetinal microbiota with the host will be studied through the mecanistic studies and various parameters of alteration of symbiosis (intestinal permeability, inflammation) and their association with psychic symptoms of anorexia nervosa.
The objective of this approche is to have not only a descrition of genomic of material of sampling, but also an overview of its potential functioning.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients:
- •Patients aged ≥18 years;
- •Anorexia according to DSM-5 and CIDI (Composite International Diagnostic Interview);
- •Body mass index (BMI) (P/T2) < 15;
- •Hospitalization for nutrition rehabilitation;
- •Covered by a health insurance;
- •Informed consent form signed.
- •For Healthy Volunteers:
- •Aged ≥18 years;
- •18.5 < BMI (P/T2) < 25;
- •Covered by a health insurance;
- •Informed consent form signed.
排除标准
- •For patients:
- •Patients no-responding all criteria of DSM-5 or CIDI scores;
- •Taken of antibiotic treatment 2 months / or laxativ 3 weeks before hospitalization;
- •Somatic comorbidity should perturb intestinal microbiota (Crohn's disease, diabetes and all other chronic inflammatory diseases);
- •Patients under guardianship;
- •Patients covered by french AME scheme.
- •For Healthy Volunteers:
- •Any disease should perturb intestinal microbiota;
- •Recent ponderal variation;
- •Taken of antibiotic treatment 2 months or laxativ 3 weeks before hospitalization;
- •Under guardianship;
- •Covered by french AME scheme.
研究组 & 干预措施
Anorexia patients
Hospitalized anorexia patients with body mass index < 15.
干预措施: Stool and blood samples (Biological)
Healthy controls
Health volunteers: 18 years or older with body mass index between 18.5 and 25.
干预措施: Stool and blood samples (Biological)
结局指标
主要结局
Eating Disorder
时间窗: at baseline
By Eating Disorder Inventory (EDI-3)
Anxio-depressive symptomatologic assessements by HAD score
时间窗: at baseline
By HAD score
Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale
时间窗: at baseline
By LSAS Lieboweitz social anxiety scale
Anxio-depressive symptomatologic assessements
时间窗: at baseline
By HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI).
Physical exercise
时间窗: at baseline
By Global physical activity questionnaire (GPAQ)
Biological parameter
时间窗: at baseline
By serum serotonin level
Anxio-depressive symptomatologic assessements by scale of Beck BDI 13
时间窗: at baseline
By scale of Beck BDI 13
Anxio-depressive symptomatologic assessements by MOCI
时间窗: at baseline
By Maudsley Obsessions and compulsions inventory (MOCI).
次要结局
- Immunity alteration(at baseline)
- EDI(at baseline)
- Gene and species richness(at baseline)
- Circulating mitochondrial DNA copy number(at baseline)
- Presence of Autistic symptoms (1)(at baseline)
- Eating Disorder Diagnostic(at baseline)
- Diversity indice(at baseline)
- Intestinal permeability(at baseline)
- Liver function(at baseline)
- BMI(at baseline)
- Body composition(at baseline)
- Intestinal functional disorders(at baseline)
- Energy expenditure(at baseline)
- Heart damage(at baseline)
- Presence of Autistic symptoms (2)(at baseline)
- Eating behaviors assessment(at baseline)