Intestinal Flora and Metabonomics of Appendicitis

NCT06035029 | Unknown

• 1 other identifier: YXLL-KY-2023 （009）
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis; Intestinal Metaplasia; Metabonomics

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Case group

Children with appendectomy for appendicitis

Control group

Children with no digestive disease or medical history

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 1-14 in Department of Pediatric Surgery in Shandong Qianfoshan Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HongyiQu: lead

Study Sites (1)

The First Affiliated Hospital Of Shandong First Medcial Unversity

Jinan, Shandong, 0531, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Before antibiotics for children in the case group, a stool sample (5-10 g) was collected from all of the included subjects and placed in a sterile enzyme-free (no RNA and DNA enzyme) cryopreservation tube. When children with appendicitis are taken to the operating room and placed under anesthesia, the patient is collected and collected after storage using sterile preservation fluid. After the appendectomy, the full length of the appendix cavity was wiped with a sterile cotton swab under a sterile environment, and then the swab was placed into a sterile collection tube. Specimens were transported and stored at-80℃ until analysis.

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Qu

  Shandong First Medical University

  STUDY CHAIR

Central Study Contacts

Qu

CONTACT

+8613905316435; qhyzhl8083@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: April 3, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)