Clinical trial NCT06035029: Intestinal Flora and Metabonomics of Appendicitis
Official title: Research on Intestinal Flora and Metabonomics of Appendicitis in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Appendicitis
Intestinal Metaplasia
Metabonomics
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 1-14 in Department of Pediatric Surgery in Shandong Qianfoshan Hospital

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The 16S rRNA gene sequence
timeFrame: up to 24 weeks
measure: Fecal untargeted metabolomics testing
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital Of Shandong First Medcial Unversity
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Qu
role: STUDY_CHAIR
References: