ive versus heat-inactivated probiotic strains in preterm infants: The Pro-Para study

Not Applicable

Completed

• Conditions: preterm infants; Diet and Nutrition - Other diet and nutrition disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12618000489291
• Lead Sponsor: King Edward Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-04
• Study Completion: 2020-04-30
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Eligibility criteria: (1) Gestation <32 weeks at birth (2) ready to commence on feeds or on feeds for less than or equal to 12 hours (3) Informed parental consent

Exclusion Criteria

(1) Congenital malformations (2) Chromosomal aberrations (3) Not ready for feeds or on feeds for >12 hours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcomes: <br>(1) Safety: Assessed by monitoring for (a) blood culture positive sepsis by the administered probiotic strains and (b) adverse effects such as abdominal distension, vomiting, and diarrhoea leading to cessation of the supplementation. <br><br>[The duration of supplementation (from starting enteral feeds and probiotic product till 37 weeks completed gestational age)];(2) Faecal calprotectin levels: Calprotectin an intestinal-specific biomarker and is elevated in different inflammatory bowel conditions including NEC. Hence we have selected it as a marker of intestinal inflammation, which is reduced by probiotic supplementation. [After 1 week and 3 weeks of commencement of supplementation with the live or para probiotic preparation.]