Fecal Keratin 8 Is a Noninvasive and Specific Marker for Intestinal Injury in Necrotizing Enterocolitis

Area of Science:

• Neonatal Medicine
• Gastroenterology
• Biomarker Discovery

Background:

• Necrotizing enterocolitis (NEC) is a critical condition in premature infants requiring reliable biomarkers for diagnosis and monitoring.
• Current diagnostic methods for NEC have limitations in specificity and invasiveness.
• There is a need for specific biomarkers to assess intestinal mucosal injury and recovery in NEC.

Purpose of the Study:

• To develop and validate a modified enzyme-linked immunosorbent assay (ELISA) for detecting total keratin 8 (K8) in infant stool.
• To investigate the clinical utility of fecal K8 as a specific marker for intestinal injury in necrotizing enterocolitis (NEC).

Main Methods:

• A modified ELISA protocol was developed to measure total keratin 8 (K8) in fecal samples.
• Fecal samples were collected from newborns with NEC and matched controls.
• Fecal calprotectin and total white blood cell (WBC) count were also measured for comparison.

Main Results:

• Fecal K8 levels were significantly elevated in infants before NEC diagnosis and during active NEC compared to controls (p=0.013, p=0.041).
• Fecal K8 levels peaked at NEC onset and decreased with disease resolution (p=0.019).
• Fecal calprotectin showed similar trends (p=0.046), but total WBC count did not (p=0.182).

Conclusions:

• A modified ELISA protocol for fecal K8 detection in newborns with NEC was successfully established.
• Elevated fecal K8 levels in NEC suggest it is a promising noninvasive biomarker for intestinal epithelial injury.
• Fecal K8 may aid in the diagnosis and monitoring of necrotizing enterocolitis in premature infants.