Effect of Probiotic dose escalation on faecal microbiota and gut inflammation in extremely preterm infants – A randomised study

Not Applicable

• Conditions: Preterm gut inflammation; Necrotising enterocolitis; Inflammatory and Immune System - Other inflammatory or immune system disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622001290785
• Lead Sponsor: Child and adoloscent health service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-04
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

: (1) gestation of <28 weeks, (2) readiness to commence on feeds or on feeds for <12 hours and (3) informed parental consent.

Exclusion Criteria

(1) congenital malformations, (2) chromosomal aberrations, (3) not ready for feeds/on feeds for more than equal to 12 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Faecal Calprotectin levels.<br>[T1: As soon as possible after birth<br>T2: Four weeks after supplementation ];2) Faecal microbiota analysis (composite outcome):(A) Faecal microbiota assessed using 16S ribosomal RNA gene sequencing. (B) Next-generation sequencing. [T1: As soon as possible after birth<br>T2: Four weeks after supplementation ]