Mechanisms affecting the gut of preterm infants

Mechanisms Affecting the Gut of Preterm Infants in Enteral feeding trials (MAGPIE)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12554594

Enrollment

480

Registered

2016-08-01

Start date

2016-07-01

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Children, Primary sub-specialty: Neonatal

Interventions

Infants who join the trial will all have been enrolled in the ELFIN study, and are anticipated to be recruited to MAGPIE at the same time in most cases i.e. within the first few days after delivery. W

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm infants <32 weeks gestation who have been enrolled into the ELFIN study of lactoferrin

Exclusion criteria

Exclusion criteria: Lack of informed consent

Design outcomes

Primary

Measure	Time frame
Gut microbial diversity (Shannon Diversity Index) and differences in the proportions of key bacterial taxa measured using 16s next generation sequencing in stool samples collected after enrolment on days 1-3, 7, 10-14, and 21 (+/- 1) days.	—

Secondary

Measure	Time frame
1. The association between the pattern of gut microbiota and the stool metabolome using mixed effect models, structural equation modelling and ordination analyses. Stool metabolome is measured using Gas Chromatography and/or Liquid Chromatography in samples collected on days 1-3, 7, 10-14, and 21 (+/- 1) days. 2. Pattern of gut microbiota prior to the onset of NEC or sepsis (diagnosed according to criteria used in the ELFIN trial) is measured using up to 7 daily stool samples in the period immediately prior to disease compared to samples from control cases who do not develop disease 3. The gut tissue inflammatory response in surgically resected gut tissue affected by NEC and in control tissue (either non-affected tissue from the same infant, or tissue from an infant requiring gut resection who does not have disease), is determined by immune-histochemistry using paraffin blocks cut into small sections for staining, a digital slide scanner and white cell infiltrates identified using antibodies. This is measured after trial completion by retrieving samples from hospital pathology archives.	—

Measure

Time frame

1. The association between the pattern of gut microbiota and the stool metabolome using mixed effect models, structural equation modelling and ordination analyses. Stool metabolome is measured using Gas Chromatography and/or Liquid Chromatography in samples collected on days 1-3, 7, 10-14, and 21 (+/- 1) days. 2. Pattern of gut microbiota prior to the onset of NEC or sepsis (diagnosed according to criteria used in the ELFIN trial) is measured using up to 7 daily stool samples in the period immediately prior to disease compared to samples from control cases who do not develop disease 3. The gut tissue inflammatory response in surgically resected gut tissue affected by NEC and in control tissue (either non-affected tissue from the same infant, or tissue from an infant requiring gut resection who does not have disease), is determined by immune-histochemistry using paraffin blocks cut into small sections for staining, a digital slide scanner and white cell infiltrates identified using antibodies. This is measured after trial completion by retrieving samples from hospital pathology archives.

—

Countries

England, United Kingdom

Contacts

Public ContactNicholas Embleton

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026