Interactions between diet and gut microbes in preterm infants

Not Applicable

Completed

• Conditions: Digestive health of preterm infants; Neonatal Diseases

• Registration Number: ISRCTN16799022
• Lead Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36857051/ (added 02/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-24
• Study Completion: 2020-02-28
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Current inclusion criteria as of 11/03/2021:
1. Preterm infants born below 30 completed weeks of gestation (<=29 weeks and 6 days)
2. Written informed consent from parents
3. Has not received any milk other than MOM

Previous inclusion criteria:
1. Preterm infants born below 29 completed weeks of gestation (<=28 weeks and 6 days)
2. Written informed consent from parents
3. Has not received any milk other than MOM

Exclusion Criteria

1. Major congenital or life threatening abnormalities
2. Inability to randomise within 48 hours of birth
3. Exposure to bovine milk product prior to randomisation
4. Likelihood of transfer to another hospital before 34 weeks postmenstrual age

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Gut microbiota bacterial diversity and proportions of specific taxa. Stool samples are collected daily and measured on <5 occasions in each infant using 16s RNA on MiSeq at 5 time points from enrolment until trial completion: days 2/3, ~7-10 (at full feeds but prior to fortifier), 10-12 (48 hours following fortifier introduction), day 21-28 and at 34 weeks corrected age (prior to trial cessation)<br> 2. Gut microbiota derived and other metabolites by measuring stool Volatile Organic Compounds using Gas Chromatography Mass Spectrometry (MS), and urine using 1H NMR and/or Liquid Chromatography MS on >=2 occasions between enrolment until trial completion (days 10-12 full feeds) and day 28<br> 3. Body composition by assessing adipose tissue mass and non-adipose tissue mass using whole body magnetic resonance imaging (MRI) at term (37-42 weeks postmenstrual age)<br>