The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Necrotizing Enterocolitis of Newborn

Intervention / Treatment
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* Other: Routine treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neonate with necrotizing enterocolitis<br>premature infants diagnosed as necrotizing enterocolitis | Other: Routine treatment<br>* Antibiotics, intravenous fluids and symptomatic supportive treatment.<br>|
| neonate without necrotizing enterocolitis<br>premature infants without necrotizing enterocolitis | Other: Routine treatment<br>* Antibiotics, intravenous fluids and symptomatic supportive treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrotizing Enterocolitis, intestinal flora