跳至主要内容
临床试验/NCT05842343
NCT05842343终止不适用

Food Intake and IgA Microbiota in Anorexia Nervosa

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
14
试验地点
2
主要终点
Total microbiotic profile

研究概览

简要总结

Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Pathophysiologic hypotheses are involving the trouble of the microbiota-gut-brain axis in the field of mental diseases.

详细描述

Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Here we aim to characterize the IgA-coated fraction of bacteria from the intestinal microbiota, linked to the regulation of the mucosal immune system and the epithelium physiology. Abnormalities of this microbiota are reported in inflammatory bowel disease and are associated to immune trouble. As food intake plays a key role in shaping microbiota, we aim to correlate data from IgA microbiota to food intake specificity, and to anorexia nervosa phenotypes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • female subject, adult, affiliated to a social security system, under the care of the eating disorder department of university hospital of st Etienne
  • presenting a diagnosis of pure restrictive anorexia nervosa.
  • For acute subgroup : BMI between 11 and 17.5 kg/m2, patient with a first episode of restrictive anorexia nervosa or with hyperphagic episodes.
  • For the chronic subgroup: BMI between 11 and 17.5 kg/m2, disease evolving for more than 5 years.
  • For Healthy volunteer: BMI between 20 and 24 kg/m², stable weight for the last 3 months, no eating disorder or history of eating disorder

排除标准

  • patient does not understand French.
  • laxative treatment in progress or stopped for less than 15 days,
  • antibiotic treatment in the two months preceding inclusion,
  • pre-pro or symbiotic treatment in progress or in the month preceding inclusion,
  • patient with one of the following comorbid disorders: celiac disease, chronic inflammatory bowel disease, lactose intolerance, unstabilized hyperthyroidism, unstabilized diabetes,
  • subject under legal protective measures.

结局指标

主要结局

Total microbiotic profile

时间窗: 1 week after inclusion

abundance and diversity parameters of the IgA microbiota fraction of the intestinal microbiota obtained by 16s rDNA analysis of stool suspension samples from acute anorexia nervosa, chronic anorexia nervosa and control subjects.

次要结局

  • Food intake characteristics(1 week after inclusion)
  • ELISA assay of fecal immunoglobulins(1 week after inclusion)
  • Microbiotic profile of total intestinal microbiota(1 week after inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验