se of probiotics to improve gut health and vaccine response in newborn babies

Not Applicable

• Conditions: Gastrointestinal microbiome; Gastroesophageal reflux; Infantile colic; Vaccine response to childhood vaccinations; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12619000369123
• Lead Sponsor: Joondalup Health Campus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-08
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Newborn infant born at > 37 week post menstrual age
2. Infant less than 72 hours of age
3. Admitted with suspected sepsis and commenced on intravenous antibiotics
4. Parents have intention to give childhood immunisations
5. Parents agree to use trial intervention and not provide other forms of probiotics

Exclusion Criteria

1. Anticipated antibiotic exposure for more than 5 days
2. Major congenital anomaly
3. Caesarean section

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Microbiome (stool sample):<br>- Proportion of potentially pathogenic bacteria (such as Enterobacteriaceae family)[4-6 week post enrolment];Gastrointestinal Microbiome (stool sample):<br>- Diversity and composition of Operational Taxonomic Units (OTU) of the stool [4-6 week post enrolment];Gastrointestinal Microbiome (stool sample):<br>- Bacterial 16S ribosomal RNA [4-6 week post enrolment]