A Study to Evaluate Breast Milk Proteins in Infant Stool


About this study

This project aims to understand protective factors present in maternal breastmilk. We hypothesize the maternal proteins will be present in infant stool of breastmilk babies in a concentration that reflects the concentration in breastmilk. Furthermore we hypothesize the concentration of proteins in both donor milk and the stool of infants fed donor milk will be decreased when compared to age matched mom’s own milk (MOM) fed infants. We will be measuring the concentration of maternal proteins in milk and stool of infants. 

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:

  • Low Birth Weight (LBW) and/or Preterm infants and mothers. Admissions to either NICU will be screened based on gestational age or birth weight.
  • Subjects included will be considered by birth weight (LBW, < 2500 grams), or gestational age (preterm, < 36 weeks). Subjects will be between the age of 3 days and 6 months old (corrected gestational age) at the time of enrollment. Cohort will be targeted to mother-infant dyads with infants born after March 2021 and ongoing through study fill.
  • Cohort will be targeted to subjects with an anticipated duration of hospitalization 2 weeks or greater.
  • Cohort will be targeted to subjects on a specified diet: either maternal milk, donor milk, or infant formula based.  
  • Written informed consent will be obtained before enrollment.

Exclusion Criteria:

  • Major congenital anomalies involving the intestinal tract.
  • Custodial issues that would prohibit consent.

Eligibility last updated 1/17/22. 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


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