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How Breast Milk and Gut Germs Affect Intestinal Illness in Preterm Babies

Role of human milk oligosaccharides and gut microbiome in necrotising enterocolitis among very preterm infants A cohort study - NECOL study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088864
Enrollment
114
Registered
2025-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Nil: Nil

Sponsors

ICMR-DHR (Indian Council of Medical Research - Department of Health Research)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inborn preterm neonates born at less than 32 weeks of gestation (very preterm neonates) will be included. The comparison groups for HMO levels and microbiome would be Neonates with NEC and Neonates without NEC.

Exclusion criteria

Exclusion criteria: Lethal congenital malformations and gastrointestinal malformations

Design outcomes

Primary

MeasureTime frame
Comparison of total and individual human milk oligosaccharide (HMO) levels between those with NEC and those without NEC and to assess the diagnostic utility of these HMO levels in predicting NEC during the neonatal period. The proportion of secretor mothers and Lewis-positive mothers between those with NEC and those without NEC.Timepoint: Within 72 hours of life, 8-10 days of life, 15-17 days of life

Secondary

MeasureTime frame
Differences in the neonatal gut and maternal milk microbiota evolution in very preterm neonates developing NEC and those without NEC.Timepoint: Within 72 hours of life, 8-10 days of life, 15-17 days of life;The association between varying levels of HMOs and maternal milk and neonatal gut microbiome.Timepoint: Within 72 hours of life, 8-10 days of life, 15-17 days of life

Countries

India

Contacts

Public ContactDr Usha Devi R

Jawaharlal Institute Of Postgraduate Medical Education and Research (JIPMER)

dr.ushaa@gmail.com9962653294

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026