Development of an in Vitro Model Based on Human Duodenal Organoids for the Study of Host-Intestinal Pathogen Interactions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Successful generation of stable and expandable human duodenal organoids from duodenal tissue
研究概览
简要总结
The goal of this clinical trial is to develop an in vitro model based on human duodenal organoids for the study of interactions between the human intestinal epithelium and enteric pathogens. Patients subjected to surgical removal of a portion of the duodenum for clinical indications, with availability of histologically normal duodenal tissue, will be asked to donate residual biological material for research purposes. The model generation procedure includes isolating intestinal stem cells from duodenal tissue, generating 3D intestinal organoids, expanding and differentiating the organoids, and inducing epithelial polarisation and maturation through air-liquid interface culture. Fully differentiated organoids will be used in in vitro co-culture experiments to assess pathogen viability, as well as the development of host epithelial responses to pathogens or their derivatives. Transcriptomic and proteomic data will also be obtained.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients subjected to surgical removal of a portion of the duodenum for clinical indications, with availability of histologically normal duodenal tissue;
- •Availability of written informed consent for the use of biological samples for research purposes.
排除标准
- •Absence of informed written consent
- •Inadequate amount of histologically normal duodenal tissue
研究组 & 干预措施
Patients subjected to surgical removal of a portion of the duodenum for clinical indications
干预措施: Donation of residual biological samples for the development of duodenal organoids. (Other)
结局指标
主要结局
Successful generation of stable and expandable human duodenal organoids from duodenal tissue
时间窗: Through study completion, an average of 18 months
次要结局
- Determination of functional changes and gene expression modulation induced in human the human epithelial compartment following co-culture with the enteric pathogens(Through study completion, an average of 18 months)
- Determination of functional changes and gene expression modulation induced in the human epithelial compartment following exposure to pathogen derivatives(Through study completion, an average of 18 months)
- Determination of modifications in pathogen morphology, development, motility and viability induced by the maintenance in the model(Through study completion, an average of 18 months)