The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

November 8, 2022 updated by: Zuohui Zhao

The Role and Mechanism of Intestinal Dysbacteriosis Impairing the Intestinal Mucosal Barrier in the Pathogenesis of Necrotizing Enterocolitis in Premature Infants

Study Description

The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are:

  • 1. Whether there is intestinal flora in the stool of premature infants.
  • 2. Are there dysregulated intestinal flora and their metabolic products in premature infants diagnosed as necrotizing enterocolitis.
  • 3. The detailed role and underlying mechanism of the intestinal dysbacteriosis and the metabolic products in premature infants diagnosed as necrotizing enterocolitis.

Participants, premature infants diagnosed as necrotizing enterocolitis (NEC group), will be asked to collect stool (usually 2 times) for intestinal flora analysis.

If there is a comparison group: Researchers will compare premature infants without necrotizing enterocolitis (control group) to see if their intestinal flora and the metabolic products also changed as their NEC counterparts.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

When the patients is hospitalized in neonatology, we screen the premature infants according to the selection criteria and exclusion criteria. After sighed the informed consent, they are classified into two groups: premature infants diagnosed as necrotizing enterocolitis (NEC group) and premature infants without necrotizing enterocolitis (control group). Their stool and blood (usually 2 times ) are collected for intestinal flora and FABP (including L-FABP and I-FABP) analysis, respectively.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • The First Affiliated Hospital of Shandong First Medical University
        • Contact:
        • Principal Investigator:
          • Zuohui Zhao, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospitalized children in Neonatology

Description

Inclusion Criteria:

  • clinical diagnosis of Necrotizing Enterocolitis,
  • gestational age <37 weeks,
  • body weight 1,000-2,500 g,
  • postnatal Apgar score ≥7,
  • initial oral feeding tolerance.

Exclusion Criteria:

  • serious hereditary or other serious diseases, such as heart, lung and abdominal malformations ,
  • early or late onset septicemia,
  • early use of antibiotics in the newborn,
  • serious adverse reactions caused by probiotics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
neonate with necrotizing enterocolitis
premature infants diagnosed as necrotizing enterocolitis
Other: Routine treatment
Antibiotics, intravenous fluids and symptomatic supportive treatment.
neonate without necrotizing enterocolitis
premature infants without necrotizing enterocolitis
Other: Routine treatment
Antibiotics, intravenous fluids and symptomatic supportive treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intestinal flora
Time Frame: up to 4 weeks
the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing
up to 4 weeks
short-chain fatty acids
Time Frame: up to 4 weeks
short-chain fatty acids, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
up to 4 weeks
neurotransmitters
Time Frame: up to 4 weeks
neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
up to 4 weeks
lipopolysaccharide
Time Frame: up to 4 weeks
lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing
up to 4 weeks
L-FABP
Time Frame: up to 4 weeks
L-FABP, the injury marker of intestinal mucosa, in the blood
up to 4 weeks
I-FABP
Time Frame: up to 4 weeks
I-FABP, the injury marker of intestinal mucosa, in the blood
up to 4 weeks
hospital stay
Time Frame: up to 4 weeks
one vital clinical outcome of the premature infants
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
X-ray
Time Frame: up to 4 weeks
one important clinical imaging data of the premature infants
up to 4 weeks
complete blood count
Time Frame: up to 4 weeks
complete blood count, one vital laboratory test of the premature infants
up to 4 weeks
c-reactive protein
Time Frame: up to 4 weeks
c-reactive protein, one vital laboratory test of the premature infants
up to 4 weeks
procalcitonin
Time Frame: up to 4 weeks
procalcitonin, one vital laboratory test of the premature infants
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuohui Zhao

Investigators

  • Principal Investigator: Zuohui Zhao, Dr, The First Affiliated Hospital of Shandong First Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 5, 2022

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2022(018)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The clinical data to collect for individual participant is not public for the time being.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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