The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

Last updated: November 8, 2022
Sponsor: Zuohui Zhao
Overall Status: Active - Recruiting

Phase

N/A

Condition

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT05619055
YXLL-KY-2022(018)
  • Ages 5-2
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.
    1. Are there dysregulated intestinal flora and their metabolic products in premature infants diagnosed as necrotizing enterocolitis.
    1. 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 30
Study Start date:
November 05, 2022
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong
    China

    Active - Recruiting

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