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Stool test may flag deadly gut disease in premature babies

NCT ID NCT07810543

Diagnosis Sponsor: Assiut University Source: ClinicalTrials.gov ↗

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First seen Sep 09, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

Researchers at Assiut University Children Hospital are measuring fecal calprotectin, a protein linked to gut inflammation, in preterm infants. The study compares levels between babies who develop necrotizing enterocolitis and those who do not, and between exclusively breastfed and exclusively formula-fed infants. The goal is to see whether calprotectin can serve as an early warning sign of this serious intestinal disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If calprotectin proves reliable, doctors could use a simple stool test to spot necrotizing enterocolitis earlier in preterm infants, when treatment works best.
What could go wrong
This is an observational study, so it can show a link but not prove that calprotectin causes or predicts NEC. Results from one hospital may not apply everywhere, and many other factors affect preterm gut health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams admitted to Assiut University Children Hospital.

Ages

Up to 36 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * \- Preterm neonates less than 36 weeks gestational age * Or low birth weight less than 1500 grams * Or both * Written informed consent from parents or legal guardians Exclusion Criteria: * \- Full-term neonates * Neonates with average birth weight * Preterm neonates with major congenital gastrointestinal anomalies or chromosomal abnormalities

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Conditions

The condition(s) this trial relates to.

Breast Feeding necrotizing enterocolitis Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast feeding Necrotizing enterocolitis Premature

How to take part

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