A Study to Evaluate Breastmilk Proteins and Sepsis


About this study

This project aims to understand the risk factors for neonatal late-onset sepsis (LOS), a leading cause of death of preterm newborns. The majority of LOS is attributable to bloodstream infections.  Survivors have a significant risk of cognitive or developmental problems, highlighting the need for identification of preventive measures and interventions for bloodstream infections. We hypothesize that stool from LOS patients will contain reduced concentration of EGF, indicative of increased intestinal permeability.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Born between after March 2021, though inclusion may be expanded to allow for recruitment of infants meeting criteria.
  • Inclusion will be based on infant's age and health status
  • Positive blood bacterial culture of possible enteric originating bacteria as defined by Dr. Levy and Dr. Knoop.
  • Birth weight (LBW, <1500 grams) or gestational age ( preterm, < 36 weeks).
  • Subjects will be between the age of 3 days and 6 months old at the time of enrollment.
  • Written informed consent will be obtained before enrollment.

Exclusion Criteria:

  • Major congenital anomalies involving the major congenital anomalies involving the GI tract, urogenital system, or another system if known to carry an infectious risk.
  • Custodial issues that would prohibit consent.

Eligibility last updated 2/17/22.  Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Knoop, Ph.D.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Kathryn Knoop Ph.D.

(507) 422-6536


More information


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