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NCT Number: NCT06072976

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

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.

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Key information

Conditions

Gastrointestinal Complication Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Gastroschisis Hernia Hernia, Abdominal Hernia, Umbilical Hernia, Ventral Hirschsprung Disease Infant, Newborn, Diseases Intestinal Diseases Intestinal Obstruction Megacolon Midgut Volvulus Musculoskeletal Abnormalities Musculoskeletal Diseases Omphalocele Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Volvulus Of Midgut

Age range

0 day–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location status: Recruiting

Location contact

Katie Strobel, MD

CONTACT

[email protected]

262-623-1987

Katie Strobel, MD

PRINCIPAL_INVESTIGATOR

Leonel Arellano

CONTACT

[email protected]

915-443-4390

Patrick Javid, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Standard of Care

Dietary Supplement

Standard of care arm: Mothers will consent to providing DHM (if qualifies per hospital policy) or formula if MOM is not available. Infants are only eligible to receive donor milk only if 1) MOM is not available 2) if infant initiates feeds before day 3 of age. The donor milk feed would be stopped on day 5 of age.

Exclusive Human Milk

Dietary Supplement

Mothers will consent to providing DHM if MOM is not available. If the infant reaches 100 ml/kg/day of feeds (one feed advancement prior to full feeds) and MOM remains unavailable, they will transition to formula in preparation for discharge. Infants cannot be discharged on donor milk.

Primary outcomes

  1. Time to full feed

    Time frame: From 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

Secondary outcomes

  1. Central line infection rate

    Time frame: up to 120 days or discharge

    To compare rate of central line infections in infants given exclusive human milk versus infants given standard care.

  2. Portion of parents own milk at time of discharge

    Time frame: Up to 120 days or discharge

    : To compare proportion of parents providing any/exclusive mother's own milk (MOM) at discharge in infants given exclusive human milk arm versus standard care arm

  3. Gut Microbiome Relative Abundance and Diversity

    Time frame: Up to 120 days or discharge

    To examine if utilization of donor milk when mother's own milk is insufficient alters the infant's gut microbiome alpha diversity and beta diversity and bacterial relative abundances

  4. Mother's milk microbiome relative abundance and diversity

    Time frame: Up to 120 days or discharge

    To discern how mother's own milk microbiome differs from donor milk microbiome relative abundances and diversity. We will examine how the milk microbiomes influences the infant's gut microbiome and time to full feeds.

  5. Concentrations of Antigen-specific immunoglobulins

    Time frame: From birth to 120 days or discharge

    To compare total and antigen-specific immunoglobulins in donor milk versus MOM

Study contacts

Contact information is provided by the study sponsor or research team.

Leonel Arellano

CONTACT

[email protected]

915-443-4390

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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