The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

N/AUnknownNCT05619055

Zuohui Zhao30 enrolled

Overview

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.

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

Conditions

Necrotizing Enterocolitis of Newborn

Interventions

Eligibility

Sex: ALLMin age: 5 DaysMax age: 2 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

intestinal flora

the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing

Time frame: up to 4 weeks

short-chain fatty acids

short-chain fatty acids, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing

Time frame: up to 4 weeks

neurotransmitters

neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing

Time frame: up to 4 weeks

lipopolysaccharide

lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing

Time frame: up to 4 weeks

L-FABP

L-FABP, the injury marker of intestinal mucosa, in the blood

Time frame: up to 4 weeks

I-FABP

I-FABP, the injury marker of intestinal mucosa, in the blood

Time frame: up to 4 weeks

hospital stay

one vital clinical outcome of the premature infants

Time frame: up to 4 weeks

Secondary Outcomes

X-ray

one important clinical imaging data of the premature infants

Time frame: up to 4 weeks

complete blood count

complete blood count, one vital laboratory test of the premature infants

Time frame: up to 4 weeks

c-reactive protein

c-reactive protein, one vital laboratory test of the premature infants

Time frame: up to 4 weeks

procalcitonin

procalcitonin, one vital laboratory test of the premature infants

Time frame: up to 4 weeks

The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts