Intestinal Flora and Metabonomics of Appendicitis

Appendicitis Clinical Trial

Official title:

Research on Intestinal Flora and Metabonomics of Appendicitis in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035029
• Other study ID #: YXLL-KY-2023 (009)
• Status: Recruiting
• Start date: April 3, 2023
• Est. completion date: July 2025

Study information

• Verified date: September 2023
• Source: Qianfoshan Hospital
• Contact: Qu
• Phone: +8613905316435
• Email: qhyzhl8083[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Appendicitis
• Intestinal Metaplasia
• Metaplasia

Locations

Country	Name	City	State
China	The First Affiliated Hospital Of Shandong First Medcial Unversity	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
HongyiQu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 16S rRNA gene sequence	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.	up to 24 weeks
Primary	Fecal untargeted metabolomics testing	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.	up to 24 weeks