Clinical trial Recruiting at 1 site Interventional Ages 0 Days to 55

Examining how different feeding methods affect gut health in newborns with gastrointestinal issues

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

Run by Seattle Children's Hospital · NCT06072976 · Data updated 2026-11-12

This study is testing whether feeding newborns with gastrointestinal issues an exclusive human milk diet helps improve their gut health and feeding progress compared to standard feeding methods.

Quick facts

Study typeInterventional
Ages0 Days to 55 Years
SexAll
Enrollment116 (estimated)
SponsorSeattle Children's Hospital
Academic / other
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedJune 9, 2023
Main results expectedJune 9, 2027
Study endsJune 9, 2027
Registry record updatedApril 30, 2026
Trial IDNCT06072976 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants diagnosed with congenital gastrointestinal conditions like gastroschisis, intestinal atresia, or Hirschsprung disease.

Probably not a fit

Patients who have already started feeding or those with certain contraindications to milk will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of an exclusive human milk diet compared to standard feeding practices on feeding outcomes and gut microbiome composition in infants with congenital gastrointestinal pathologies. By focusing on conditions such as gastroschisis and Hirschsprung disease, the research aims to determine how these feeding sources influence the time to achieve full feeds. The study will enroll eligible infants and monitor their feeding progress and gut health over a specified period.

Why it matters

Potential benefit: If successful, this study could lead to improved feeding strategies that enhance gut health and recovery in vulnerable neonates.

How similar studies have gone: While the specific approach of this study may be novel, previous research has indicated that human milk can positively influence gut health in neonates.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.

Exclusion Criteria:

1. Infant has already been on feeds
2. Infants \<34 weeks gestation
3. Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy/suboxone/marijuana OK)
4. Complicated gastroschisis
5. Short gut syndrome
6. Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)

Where it's running

  • Seattle Children's Hospital
    Seattle, Washington, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.