Tiny preemies, big gut mystery: can bacteria predict a deadly condition?
NCT ID NCT07667049
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times
Summary
This study looks at how 'leaky' the gut is and what bacteria live in the intestines of 150 very low birth weight preterm babies. Researchers want to understand why some babies develop a life-threatening gut emergency called NEC. They will measure gut permeability using harmless sugars and analyze stool samples to track gut bacteria over time.
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 successful, this research could point toward ways to detect or prevent a life-threatening gut condition called NEC in premature babies.
- What could go wrong
- This is an early observational study, not a treatment trial. It may not lead to any direct medical changes, and the findings may not apply to all preterm infants.
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.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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Up to 4 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \<5 days Gestational age 24-32 weeks Exclusion Criteria: Nonviable or planned withdrawal of care * Significant GI dysfunction (e.g. heme-positive stools, abdominal distension (girth \>2 cm baseline), or bilious emesis/ aspirates. * Triplet or higher order multiple * Severe asphyxia * Lethal chromosome abnormalities * Cyanotic congenital heart disease * Intestinal atresia or perforation * Abdominal wall defects * Known galactosemia or other galactose intolerance
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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