drugset / Trial / NCT03266315

Probiotics Supplementation and Intestinal Microbiome in Neonates With Gastrointestinal Surgery

NCT03266315

Terminated 2 enrolled University of Calgary
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Probiotics Other / unclassified Oral