UnknownNot Applicable

The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

China30 participantsStarted 2022-11-05

Plain-language 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.

Who can participate

Age range

5 Days – 2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

intestinal flora

Timeframe: up to 4 weeks

short-chain fatty acids

Timeframe: up to 4 weeks

neurotransmitters

Timeframe: up to 4 weeks

lipopolysaccharide

Timeframe: up to 4 weeks

L-FABP

Timeframe: up to 4 weeks

I-FABP

Timeframe: up to 4 weeks

hospital stay

Timeframe: up to 4 weeks

Trial details

NCT IDNCT05619055

SponsorZuohui Zhao

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-31

Contact for this trial

Zuohui Zhao, Dr

0086-531-89268509 zhaozuohui@126.com

View on ClinicalTrials.gov More Necrotizing Enterocolitis of Newborn trials

Plain-language summary

Who can participate

Age range

5 Days – 2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.