The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis
- Conditions
- Necrotizing Enterocolitis of Newborn
- Interventions
- Other: Routine treatment
- Registration Number
- NCT05619055
- Lead Sponsor
- Zuohui Zhao
- Brief 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.
* 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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- clinical diagnosis of Necrotizing Enterocolitis,
- gestational age <37 weeks,
- body weight 1,000-2,500 g,
- postnatal Apgar score ≥7,
- initial oral feeding tolerance.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description neonate with necrotizing enterocolitis Routine treatment premature infants diagnosed as necrotizing enterocolitis neonate without necrotizing enterocolitis Routine treatment premature infants without necrotizing enterocolitis
- Primary Outcome Measures
Name Time Method short-chain fatty acids up to 4 weeks short-chain fatty acids, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
L-FABP up to 4 weeks L-FABP, the injury marker of intestinal mucosa, in the blood
I-FABP up to 4 weeks I-FABP, the injury marker of intestinal mucosa, in the blood
hospital stay up to 4 weeks one vital clinical outcome of the premature infants
intestinal flora up to 4 weeks the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing
lipopolysaccharide up to 4 weeks lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing
neurotransmitters up to 4 weeks neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
- Secondary Outcome Measures
Name Time Method procalcitonin up to 4 weeks procalcitonin, one vital laboratory test of the premature infants
X-ray up to 4 weeks one important clinical imaging data of the premature infants
c-reactive protein up to 4 weeks c-reactive protein, one vital laboratory test of the premature infants
complete blood count up to 4 weeks complete blood count, one vital laboratory test of the premature infants
Trial Locations
- Locations (1)
The First Affiliated Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China