Intestinal Flora and Metabonomics of Appendicitis | NCT06035029

Studies
Intestinal Flora and Metabonomics of Appendicitis

NCT06035029

Sponsor

HongyiQu

Status

Unknown status

Last Update Posted

Sep 13, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Appendicitis
Intestinal Metaplasia
Metabonomics

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2023Actual

Primary Completion Date

Jan 2025Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

Aug 28, 2023

First Submission Date that Met QC Criteria

Sep 5, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case group		Children with appendectomy for appendicitis
Control group		Children with no digestive disease or medical history

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

14 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qu	Contact	+8613905316435		qhyzhl8083@126.com

Overall Officials

Name	Affiliation	Role
Qu	Shandong First Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital Of Shandong First Medcial Unversity	Recruiting	Jinan	Shandong	0531	China

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.