Outbreak of Gastrointestinal Sepsis Associated with Bacillus cereus-Contaminated Human Milk Fortifier in Preterm

Wrik Laha1, Choudri Muzafar Paswal1, Swasthi Kabi Satpathy1

  • 1Department of Neonatology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, 342005, India.

Indian Pediatrics
|April 1, 2026
PubMed

Insights

A batch of powdered human milk fortifier (HMF) contaminated with Bacillus cereus caused severe gastrointestinal illness in preterm neonates. Prompt removal of the HMF batch and enhanced infection control prevented further cases.

Area of Science:

  • Neonatal Medicine
  • Microbiology
  • Public Health

Background:

  • Powdered human milk fortifier (HMF) is crucial for preterm neonate nutrition.
  • Contamination of infant nutrition products poses significant health risks.
  • Neonatal intensive care units (NICUs) require stringent infection control.

Purpose of the Study:

  • To investigate a cluster of acute gastrointestinal illness in preterm neonates.
  • To identify the source and causative agent of the outbreak.
  • To inform preventative strategies for HMF contamination in NICUs.

Main Methods:

  • Case-series investigation of affected neonates.
  • Microbiological analysis of implicated powdered human milk fortifier (HMF) batches.
  • Review of infection-control practices.

Main Results:

  • Seven preterm neonates developed severe gastrointestinal illness, including diarrhea, dehydration, hypoglycemia, and shock, within hours of ingesting HMF.
  • Blood and stool cultures from neonates were sterile.
  • Microbiological analysis detected Bacillus cereus and other spore-forming organisms in unopened HMF sachets.
  • No further cases occurred after the contaminated HMF batch was withdrawn and infection-control measures were reinforced.

Conclusions:

  • Contamination of powdered HMF with Bacillus cereus can lead to severe outbreaks of gastrointestinal illness in vulnerable preterm neonates.
  • This outbreak underscores the critical importance of rigorous quality control and microbiological surveillance of powdered HMF.
  • Enhanced infection-control protocols are essential in NICUs to prevent and manage potential HMF-related contamination events.

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