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Intestinal Colonization in Newborn Infants With Enterostomy

NCT03340259 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2017-11-13

No results posted yet for this study

Summary

The human microbiota, a collection of microorganisms mostly settled in the gastrointestinal tract, plays a major role in the maintenance of the hosts' health and in development of disease as well. Exposure to different conditions early in life contributes to distinct "pioneer" bacterial communities, which shape the newborn infants' development and influence their later physiological, immunological and neurological homeostasis. Newborn infants with congenital malformations of the gastrointestinal tract (CMGIT), necrotizing enterocolitis (NEC), and spontaneous intestinal perforation (SIP) commonly require abdominal surgery and enterostomy. While intestinal microbiota has been extensively studied in infants with anatomically uninterrupted intestine, the knowledge of longitudinal intestinal colonization in this population is scarce.

This is an exploratory, observational, and longitudinal prospective study, primarily aimed to determine longitudinally the colonization of the proximal remnant intestine, in newborn infants with enterostomy after surgery (three weeks) for CMGIT, NEC and SIP. The secondary aim is to explore the associations of the colonization with the mode of delivery, gestational age, postnatal age, duration of fasting, type of enteric feeding, antimicrobial therapy, H2-receptor antagonist therapy, and length of proximal remnant intestine.

Conditions

  • Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation

Interventions

PROCEDURE

Exposure(s) of interest: enterostomy

Newborn infants with congenital malformations of the gastrointestinal tract, necrotizing enterocolitis, and spontaneous intestinal perforation commonly require surgery and enterostomy. In these infants samples of the enterostomy effluent will be collected and DNA extracted for microbiota identification.

Sponsors & Collaborators

  • CINTESIS - Center for Health Technology and Services Research, Porto

    collaborator UNKNOWN

  • Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisboa

    collaborator UNKNOWN

  • Universidade Nova de Lisboa

    collaborator OTHER

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Luís Pereira-da-Silva, MD, PhD · Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central

  • Conceição Calhau, PhD · Universidade Nova de Lisboa

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03340259 on ClinicalTrials.gov