Intestinal Metagenome of Undernourished in Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Evaluation of change of the gut microbiota in undernourished inpatients with anorexia nervosa compared to healthy subjects.
研究概览
简要总结
The objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition.
详细描述
This is a prospective, comparative, non-interventional study involving one clinical nutrition unit in France. Gut microbial will be evaluated with feces between patients and healthy volunteers.
Main investigations:
- Presence of gut microbial deviation compared to healthy volunteers;
- Presence of a significant statistical association between this deviation and metabolic disorders.
For each patient under the routine care a clinical examination and a blood sample will be done for standard biology report and nutrition. The age, gender, weight, height (for calculation of BMI), type of anorexia nervosa will be also collected with the pathological behavior associated (physical and intellectual hyperactivity, potomania, ongoing supplements drug taking including vitamins and trace elements). Eating and psychological disorders will be evaluated with EDI (eating disorder inventory) questionnaire.
Only the age, gender, height, weight (BMI), medical antecedents and ongoing treatment taking will be collected.
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
- •Anorexia nervosa as defined by DSM-5 (Diagnostic and Statistics Manual of Mental disorders
- •Undernutrition defined by BMI under 15
- •Age superior to 18
- •Patient hospitalised for undernutrition or seen in hospital day
- •Affiliation to the French social security regime or a similar regime
- •Patient signed informed consent
- •Healthy volunteers:
- •Age superior to 18
- •Normal weight (BMI 18.5 - 25)
- •Affiliation to the French social security regime or a similar regime
- •Patient signed informed consent
排除标准
- •Taking antibiotics two month before hospitalization
- •Purge line with laxative abuse one month before hospitalization
- •Another disease may be associated to microbiota profile modification (diabetes, MICI or digestive organ pathology, metabolic disease)
- •Obesity prior to anorexia nervosa
- •Safeguard justice procedure
- •Healthy volunteers:
- •Metabolic anomaly
- •Recent weight change
结局指标
主要结局
Evaluation of change of the gut microbiota in undernourished inpatients with anorexia nervosa compared to healthy subjects.
时间窗: 1 day
次要结局
- Presence of a significant statistical association between this changes and metabolic troubles.(1 day)