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临床试验/NCT06035029
NCT06035029招募中不适用

Research on Intestinal Flora and Metabonomics of Appendicitis in Children

HongyiQu1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Fecal untargeted metabolomics testing

研究概览

简要总结

The goal of this observational study is to learn about the key bacterial flora and metabolites associated with appendicitis in children. The main questions it aims to answer are:

  • To screen out the key biomarkers of pediatric appendicitis.
  • What are the microbial differences in different parts of pediatric appendicitis patients.

Participants will detect feces using 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing technology and differences of the fecal metabolites between healthy children and appendicitis children were analyzed using untargeted metabolomics based on Liquid chromatography-tandem mass spectrometry(LC-M S/MS) platform.Through the analysis of intestinal bacterial flora and metabolomics association and the differential analysis of intestinal bacterial flora in different parts of the case group, the key bacterial flora and metabolites were excavated.

详细描述

Participants will detect feces using 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing technology and differences of the fecal metabolites between healthy children and appendicitis children were analyzed using untargeted metabolomics based on Liquid chromatography-tandem mass spectrometry(LC-M S/MS) platform.

Differences in the intestinal flora of different parts of the case group: the intestinal flora of the case group in feces and rectum were detected by 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing technology, and the intestinal flora of different parts were analyzed and compared.

Through the analysis of intestinal bacterial flora and metabolomics association and the differential analysis of intestinal bacterial flora in different parts of the case group, the key bacterial flora and metabolites were excavated.

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
1 Year 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 1-14 years who were initially diagnosed with appendicitis and underwent laparoscopic appendectomy
  • Children aged 1-14 years with non-digestive tract disease and no history of digestive tract disease

排除标准

  • A family history of intestinal disease
  • Allergic to antibiotic therapy drugs
  • Patients with long-term drug use causing microbial structure changes or intestinal flora disorders
  • Patients with other congenital diseases such as Meckel's diverticulum, intestinal rotation and other malrotation
  • With other systemic diseases, such as obvious upper respiratory tract infection or myocarditis
  • Children with other digestive system diseases after auxiliary examination or surgical diagnosis

结局指标

主要结局

Fecal untargeted metabolomics testing

时间窗: up to 24 weeks

To analyze the fecal metabolite differences and the correlation of appendicitis and metabolites using untargeted metabolomics based on the LC-M S/MS platform. To screen key metabolites in pediatric appendicitis.

The 16S rRNA gene sequence

时间窗: up to 24 weeks

Samples were qualified for Polymerase Chain Reaction(PCR) amplification of the V3 and V4 variable regions of the 16 rRNA gene. The Polymerase Chain Reaction(PCR) products were then quantified by confirming the presence of PCR amplicons by gel electrophoresis on a 2% agarose gel and staining with ethidium bromide, and equimolar amounts (100 ng) of PCR amplicons were pooled prior to pyrosequencing. High-throughput sequencing of the qualified 16S amplicon libraries.

次要结局

未报告次要终点

研究者

发起方
HongyiQu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

HongyiQu

professor

Qianfoshan Hospital

研究点 (1)

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