The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

Zuohui Zhao

Status: Enrolling

Conditions: Necrotizing Enterocolitis of Newborn

Treatments: Other: Routine treatment

Study type: Observational

Funder types: Other

Identifiers

NCT05619055

YXLL-KY-2022(018)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 days to 2 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

neonate with necrotizing enterocolitis

Description:

premature infants diagnosed as necrotizing enterocolitis

Treatment:

Other: Routine treatment

neonate without necrotizing enterocolitis

Description:

premature infants without necrotizing enterocolitis

Treatment:

Other: Routine treatment