Feeding Source and Gut Health in Infants with Intestinal Conditions

This study is looking at how different feeding methods affect the gut (digestive system) and how quickly infants with certain intestinal problems can start eating normally. It compares two approaches: an "Exclusive Human Milk" diet, where infants receive human milk (from their mother or a donor), versus "Standard of Care," which might include formula if mother's milk isn't available. The study is for infants from birth up to 55 years old who have conditions like gastroschisis (intestines outside the body), omphalocele (intestines covered by a sac outside the body), or Hirschsprung disease (a nerve problem in the large intestine). The main goal is to see which feeding method helps infants reach full feeds faster. The study plans to enroll 116 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing two feeding approaches in 116 planned participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from birth to 120 days or until discharge to measure the time to full feed.

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NCT06072976

The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies

Recruiting
NAAges 0–55InterventionalSupportive care
Seattle Children's Hospital
~116 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Standard of CareExclusive Human Milk

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to full feed
Measured over From birth to 120 days or until discharge
Gastrointestinal Complication
Intestinal Obstruction
Gastroschisis
Hirschsprung Disease
Omphalocele
Midgut Volvulus
1 sites across 1 states
Washington1
  • Katie Strobel, MD · PRINCIPAL_INVESTIGATOR · Seattle Children's Hospital

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Eligibility criteria

Inclusion

Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.
  • Time to full feedFrom birth to 120 days or until discharge

    : In infants with congenital gastrointestinal pathologies (gastroschisis, giant omphalocele, atresia, midgut volvulus, Hirschsprung disease, CGP), to determine if use of an exclusive human milk diet will decrease the number of days to full feeding volume (120 ml/kg/day) (29 subjects per power calculation) compared to human milk/formula