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Probiotics Supplementation and Intestinal Microbiome in Neonates With Gastrointestinal Surgery

NCT03266315 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-07-18

No results posted yet for this study

Summary

Congenital defects of the gastrointestinal tract commonly require surgical intervention in the neonatal period. Intestinal surgery during this critical period of microbiome acquisition results in aberrant colonization of the gastrointestinal tract by several pathways. Surgical stress is known to cause disruption of the gut barrier and increase intestinal permeability and bacterial translocation. This process triggers exaggerated immune responses that lead to inflammation and sometimes infectious complications. Post-operative use of antibiotics has been shown to potentiate the growth of pathogenic bacterial species Adults with abdominal surgery who received post-op probiotics reported a significant reduction in surgical site infection, urinary tract infection, and combined infection. Currently, probiotics used only in the non-surgical population of infants.

The main objective of this study is to determine the impact of probiotics administration on the intestinal microbiome in neonates undergoing intestinal surgery.

Conditions

  • Probiotics
  • Infant, Newborn
  • Surgical Procedures, Operative
  • Gastro-Intestinal Disorder

Interventions

BIOLOGICAL

FloraBaby

1 sachet will be added to a minimum of 1 mL of brest milk, sterile water or formula (in formula fed babies) once a day

OTHER

Placebo

1 sachet will be added to a minimum of 1 mL of brest milk, sterile water or formula (in formula fed babies) once a day

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Alixe Howlett, MD · University of Calgary

  • Belal N Alshaikh, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-03
Primary Completion
2024-07-15
Completion
2024-07-15

Countries

  • Canada

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 NCT03266315 on ClinicalTrials.gov