Examining how different feeding methods affect gut health in newborns with gastrointestinal issues
The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 0 Days to 55 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06072976 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants diagnosed with congenital gastrointestinal conditions like gastroschisis, intestinal atresia, or Hirschsprung disease.
Not a fit: Patients who have already started feeding or those with certain contraindications to milk will not benefit from this study.
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 performed: While the specific approach of this study may be novel, previous research has indicated that human milk can positively influence gut health in neonates.
Eligibility criteria
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 this trial is running
Seattle, Washington
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Katie Strobel, MD — Seattle Children's Hospital
- Study coordinator: Leonel Arellano
- Email: leonel.arellano@seattlechildrens.org
- Phone: 915-443-4390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.