Probiotics Supplementation and Intestinal Microbiome in Neonates With Gastrointestinal Surgery

NCT03266315 | Terminated

• 1 other identifier: REB16-2401
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Intestinal microbiome

  Stool microbiome

  3 weeks after surgury

Secondary Outcomes (1)

• Length of hospital stay

  6 months

Study Arms (2)

Probiotics

EXPERIMENTAL

subjects will be randomly assigned to receive FloraBaby

Biological: FloraBaby

Placebo

PLACEBO COMPARATOR

subjects will be randomly assigned to receive placebo

Other: Placebo

Interventions

FloraBaby BIOLOGICAL

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

Also known as: Probiotics

Probiotics

Placebo OTHER

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

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants born between 23 - 41 weeks of gestation
• Required gastrointestinal surgery (including spontaneous intestinal perforation, bowel atresia, mechanical bowel obstruction, volvulus, gastroschisis)
• Ready to start enteral feeding

You may not qualify if:

• Infants with major congenital anomalies excluding gastrointestinal tract
• Palliative care patients
• \. Septic babies with positive blood, CSF or urine culture

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T3M1M4, Canada

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Alixe Howlett, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Belal N Alshaikh, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Department of Pediatrics

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 30, 2017
• Study Start: December 3, 2022
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)