The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

Necrotizing Enterocolitis of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05619055
• Other study ID #: YXLL-KY-2022(018)
• Status: Recruiting
• Start date: November 5, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2022
• Source: Qianfoshan Hospital
• Contact: Zuohui Zhao, Dr
• Phone: 0086-531-89268509
• Email: zhaozuohui[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Days to 2 Months

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis
• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis of Newborn

Intervention

Other:
• Routine treatment
Antibiotics, intravenous fluids and symptomatic supportive treatment.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Zuohui Zhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intestinal flora	the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing	up to 4 weeks
Primary	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
Primary	neurotransmitters	neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing	up to 4 weeks
Primary	lipopolysaccharide	lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing	up to 4 weeks
Primary	L-FABP	L-FABP, the injury marker of intestinal mucosa, in the blood	up to 4 weeks
Primary	I-FABP	I-FABP, the injury marker of intestinal mucosa, in the blood	up to 4 weeks
Primary	hospital stay	one vital clinical outcome of the premature infants	up to 4 weeks
Secondary	X-ray	one important clinical imaging data of the premature infants	up to 4 weeks
Secondary	complete blood count	complete blood count, one vital laboratory test of the premature infants	up to 4 weeks
Secondary	c-reactive protein	c-reactive protein, one vital laboratory test of the premature infants	up to 4 weeks
Secondary	procalcitonin	procalcitonin, one vital laboratory test of the premature infants	up to 4 weeks