Gut permeability and microbiome in preterm infants
Official title: Gut Permeability and Microbiome in Very Low Birth Weight Preterm Neonates.
Run by University of Maryland, Baltimore · NCT07667049 · Data updated 2026-11-12
This study tests a dual sugar probe test to measure gut permeability in very preterm babies to understand their risk for serious gut disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 4 Days |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | September 30, 2026 |
| Main results expected | October 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07667049 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preterm infants born at 24–32 weeks gestation who are under 5 days old and where withdrawal of care is not planned.
✕Probably not a fit
Infants with significant GI dysfunction, major congenital anomalies, or other exclusion criteria may not benefit from this assessment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional study investigates how intestinal permeability relates to the gut microbiome in preterm infants born at 24–32 weeks. The primary intervention is measurement of intestinal permeability, using a dual sugar probe approach, to characterize the gut barrier in the first days of life. The study aims to identify early markers that may signal risk for NEC and related complications, with careful safety monitoring in a neonatal ICU setting. Findings could inform strategies for earlier detection and potential interventions to protect gut health in this vulnerable population.
Why it matters
Potential benefit: If successful, the study could improve early identification of infants at risk for NEC by revealing gut barrier and microbiome signatures.
How similar studies have gone: Prior research has shown associations between gut permeability, microbiome composition, and NEC risk in preterm infants, supporting the approach's relevance.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Maryland
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Marcela Pasetti, PhD — University of Maryland
- Study coordinator: Sripriya Sundararajan, MD
- Email: ssundararajan@som.umaryland.edu
- Phone: 4103286003
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.