Autophagic Activity Characterization in Pediatric Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Quantification of autophagic flux by western blot.
研究概览
简要总结
Crohn's disease is a multifactorial complex disease resulting in a between microbiota and immune system. Indeed, GWAS (Genome-Wide Association Studies) association study pinpointed polymorphisms as genes susceptibility on more than 200 loci. Among them genes coding for proteins involved in autophagy machinery (i.e: ATG16L1, IRGM et NDP52). Autophagy is a ubiquitous intracellular mechanism mandatory for protein and microorganism recycling.
So far, the role of autophagy in gut inflammation and intestinal homeostasis in Crohn's disease patients is partially understand. Then, investigators plan to evaluate, on native cells, the autophagic flux in pediatric patients suffering of a Crohn's disease compare to controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Crohn's Disease group :
- •Age between 6 and 17 inclusive
- •Patients with a weight > 25 kg at the time of inclusion
- •Patients with Crohn's disease requiring ileocolonoscopy (diagnosis or follow-up)
- •Mild to severe Crohn's disease consistent with PCDAI disease activity score
- •Patients on nutritional therapy (Modulen/Modulife), corticosteroids, salicylic derivatives, immunosuppressants, biotherapies (anti-TNF, vedolizumab and ustekinumab) or without treatment
- •Consent form signed by the patient or the holder(s) of parental authority.
- •Affiliation to a social security scheme or beneficiaries of a similar scheme.
- •For Control group:
- •Between 6 and 17 years old included
- •Presenting a weight > 25 kg at the time of inclusion
- •Without a diagnosis of Crohn's disease
- •Requiring evaluation by ileoendoscopy
- •Consent form signed by the patient or the holder(s) of parental authority.
- •Affiliation to a social security scheme or beneficiaries of a similar scheme.
排除标准
- •Refusal to participate in the protocol
- •Intercurrent infection
- •Ongoing antibiotic treatment
- •Patient involved in another interventional study protocol including an exclusion period still in progress at pre-inclusion
- •Pregnant, parturient or breastfeeding women (on questioning)
- •Persons deprived of their liberty by a judicial or administrative decision
- •Persons subject to psychiatric care
- •Persons admitted to a health or social establishment for purposes other than research
结局指标
主要结局
Quantification of autophagic flux by western blot.
时间窗: 1 day (during hospitalization for ileocolonoscopy)
LC3II/LC3I will be measured by western blot after booking the autophagic flux at different time point.
次要结局
- Incidence of autophagic polymorphisms in pediatric Crohn's disease population(1 day (during hospitalization for ileocolonoscopy))