Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Identification of gut microbiota biomarkers - metabolites
研究概览
简要总结
This study will investigate the link between the gut microbiota, the occurrence of the central adiposity phenotype, and the patients' fear to regain weight in anorexia nervosa.
详细描述
Excessive concerns about body shape and intense fear of becoming fat are among the core features of Anorexia Nervosa (AN). During refeeding, patients commonly report a disproportionate deposition of fat in the abdomen which could represent an obstacle for weight gain. It is not known whether these complaints are caused by dysmorphophobia or if the distribution of fat during refeeding could really not be uniform. Indeed, a "central adiposity phenotype" has already been objectified by anthropometric measures or imaging, with a higher proportion of visceral fat accumulated in the abdomen during the refeeding. This phenomenon could exacerbate body shape concerns and ultimately lead to an elevated risk of resistance to treatment and/or relapse.
The present research project aims to explore the mechanisms that underlie these difficulties, especially by investigating the link between the gut microbiota (both composition and products) and the occurrence of the central adiposity phenotype, and the patients' fear to regain weight.
Patients with severe to extreme anorexia nervosa admitted at hospital for refeeding will be included.
To describe patients included, a short clinical examination will be performed during the first week after inclusion, including several measures (sociodemographic data, medical history, history of eating disorders, current symptomatology of AN, and a dietary survey).
To investigate the gut microbiota biomarkers in stool (composition, diversity and richness, and metabolites), stool samples will be collected during the first week after inclusion and during the last week before discharge, together with information useful to stool sample analyses (related to stool consistency, intestinal transit, abdominal pain or discomfort, and psychoactive substance and prebiotics use).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Over 15 years old and 3 months.
- •Admitted in the specialized department for eating disorders of CHU Nantes for refeeding.
- •With a diagnosis of anorexia nervosa at admission (restrictive or Binge-Eating-Purging type).
- •Body Mass Index at admission below 16 kilogram per square meter.
- •Written informed consent for patients over 18 years old/ oral informed consent from both the patient and a legal representative for patients under 18 years old.
- •Affiliated with French social security system or beneficiary from such system.
排除标准
- •Pregnant and breastfeeding women.
- •Who received a treatment with antibiotic/antifungal (other than local application) in the last three months.
- •Who had a weight gain in the last month (5% or more of the patient's weight at admission).
- •Under trusteeship or guardianship.
- •Not fluent in French
- •Who participate in another interventional study involving medication.
- •Patients for whom stool collection or body mass composition analysis (with Dual-energy X-ray absorptiometry) couldn't be done during the first week of hospitalisation.
结局指标
主要结局
Identification of gut microbiota biomarkers - metabolites
时间窗: At inclusion
Levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry on blood and stool samples collected at inclusion, between those who express or not the central adiposity phenotype.
Identification of gut microbiota biomarkers - composition
时间窗: At inclusion
Species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype.
Identification of gut microbiota biomarkers - diversity and richness
时间窗: At inclusion
α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype
次要结局
- Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - composition(At inclusion)
- Variation of the diversity and richness of the gut microbiota between admission and discharge(At discharge, anticipated average 10 weeks)
- Variation of the metabolites of the gut microbiota between admission and discharge(At discharge, anticipated average 10 weeks)
- Identification of the central adiposity phenotype(At inclusion)
- Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - diversity and richness(At inclusion)
- Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - metabolites(At inclusion)
- Variation of the composition of the gut microbiota between admission and discharge(At discharge, anticipated average 10 weeks)