NIH-funded research NIH-funded research

Stool test to detect NEC early in premature babies

Official title: Development of a Stool-Based Screening Method for the Early Detection of Necrotizing Enterocolitis in Premature Neonates

Funded at Signature Diagnostics INC · NIH-11409713 · Data updated 2026-11-12

A new stool-based test looks for DNA methylation signs of tissue injury to detect necrotizing enterocolitis early in preterm infants.

Quick facts

Grant typeNIH-funded research
Study typeNIH-funded research
Funding institutionSignature Diagnostics INC
NIH-funded
Lab location1 site (Pittsburgh, United States)
Project startSeptember 20, 2026
Project endSeptember 19, 2027
Funding year2026
Award (this year)$306,510
NIH project number1R41HD122600-01
Project IDNIH-11409713 on NIH RePORTER

Who could benefit from this research

Could help

Premature neonates at risk for NEC who can provide stool samples for analysis.

Less likely to help

Very late NEC cases or infants not eligible for stool testing may not benefit.

What this research studies

This project aims to create a stool-based diagnostic that can signal NEC before symptoms become severe, using DNA methylation patterns found in stool. Researchers will build a reference atlas of DNA methylation across neonatal cell types and then develop a targeted, high-sensitivity assay to measure those signals in stool samples. The goal is a noninvasive test that helps clinicians diagnose NEC earlier and reduce the need for surgery and high mortality in preterm babies.

Why it matters

Potential benefit: If successful, the test could enable earlier, noninvasive NEC detection and potentially improve survival and outcomes for premature infants.

How similar studies have gone: Previous work shows NEC-associated DNA methylation changes in stool; translating these findings into a practical assay is the next step.

Where this research is happening

  • Signature Diagnostics INC
    Pittsburgh, United States
    Active

Researchers

  • Principal investigator: Gandhi, Francis Amrit Raj — Signature Diagnostics INC
  • Study coordinator: Gandhi, Francis Amrit Raj

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.