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

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This study explores the use of an exclusive human milk diet versus standard feeding practices to compare the influence on feeding outcomes and the gut bacteria in infants with intestinal differences.

Conditions:

Gastrointestinal Complication Intestinal Obstruction Gastroschisis Hirschsprung Disease Omphalocele Midgut Volvulus

Study Start (Actual) 2023-06-09

Primary Completion (Estimated) 2025-06-09

Study Completion (Estimated) 2025-06-09

Enrollment (Estimated) 116

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 Seattle, Washington, United States

Eligibility Criteria

Description

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)

Ages Eligible for Study: 0 Days to 55 Years (CHILD, ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-08-08
First Submitted that Met QC Criteria2023-10-03
First Posted2023-10-10

Study Record Updates

Last Update Submitted that Met QC Criteria2023-10-03
Last Update Posted2023-10-10
Last Verified2023-10