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Intestinal Flora and Metabonomics of Appendicitis

Sponsor
HongyiQu (Other)
Overall Status
Recruiting
CT.gov ID
NCT06035029
Collaborator
(none)
30
Enrollment
1
Location
26.9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Research on Intestinal Flora and Metabonomics of Appendicitis in Children
    Actual Study Start Date :
    Apr 3, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Case group

    Children with appendectomy for appendicitis
    Control group

    Children with no digestive disease or medical history

    Outcome Measures

    Primary Outcome Measures

    1. The 16S rRNA gene sequence [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.

    2. Fecal untargeted metabolomics testing [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital Of Shandong First Medcial Unversity Jinan Shandong China 0531

    Sponsors and Collaborators

    • HongyiQu

    Investigators

    • Study Chair: Qu, The First Affiliated Hospital of Shandong First Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HongyiQu, professor, Qianfoshan Hospital
    ClinicalTrials.gov Identifier:
    NCT06035029
    Other Study ID Numbers:
    • YXLL-KY-2023 （009）
    First Posted:
    Sep 13, 2023
    Last Update Posted:
    Sep 13, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Appendicitis
    Metaplasia

    Study Results

    No Results Posted as of Sep 13, 2023