Defining the Intestinal Microbiota in Premature Neonates

Necrotizing Enterocolitis Clinical Trial

Official title:

The Microbiota of the Premature Neonatal Gastrointestinal Tract: Its Development and Relation to Necrotizing Enterocolitis and Bloodstream Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102738
• Other study ID #: CR01542
• Status: Completed
• Start date: January 2011
• Est. completion date: June 2014

Study information

• Verified date: April 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will collect daily faecal samples from premature (<32 weeks) infants in the intensive care unit from the day of birth until they are discharged. By using newly developed molecular detection techniques the investigators aim to define more precisely than has ever previously been attempted, all the species of bacteria present in the faeces. This will enable comparison of the pre-morbid and post-morbid intestinal microbiota (all the bacteria in the gut) in premature neonates.

Description:

Highly premature infants are susceptible to serious infections such as necrotizing enterocolitis (NEC) and late-onset blood stream infections (BSIs).

NEC is a poorly understood, potentially life-threatening bowel disorder. It is thought that bacteria proliferating abnormally in the bowel may play an important part in its cause, but no single pathogen has yet been identified.

BSIs are commonly caused by gut bacteria. As the highly premature gut is fragile and has increased permeability, poor motility and decreased immune defences, localised inflammation caused by abnormal bacterial growth may allow 'bystander' microbes to translocate through the gut into the blood stream leading to systemic infection.

In a small proportion of infants who develop NEC, surgery will be required as part of treatment of the condition. In these infants the investigators will seek consent to collect a small part of the diseased bowel which has been removed. Similar analysis will be performed on these samples. The analysis of the tissue samples will give us an indication of how well the faeces act as a proxy for the intestinal microbiota.

In this ecological study of the evolution of the intestinal microbiota in preterm infants, by comparing samples from babies who develop NEC or late-onset BSI with those of well babies the investigators will be able to look for differences characteristic of the conditions. This information will help aid design of prevention or treatment strategies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: June 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

Inclusion Criteria:

• All premature babies born at less than 32 completed weeks gestation who are admitted to an Imperial College NHS Healthcare Trust Neonatal Intensive Care Unit (St. Mary's Hospital or Queen Charlotte's & Chelsea Hospital), and whose parents/guardians have given their consent will be eligible to enter the study.

Exclusion Criteria:

• All babies born at more than 32 completed weeks gestation will be excluded from the study.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Infection
• Late Onset Bloodstream Infection
• Necrotizing Enterocolitis
• Premature Birth
• Premature Intestinal Microbiota

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London
United Kingdom	Queen Charlotte's and Chelsea Hospital - NICU	London
United Kingdom	St. Mary's Hospital - Winnicott Baby Unit	London

Sponsors (4)

Lead Sponsor	Collaborator
Imperial College London	Chelsea and Westminster NHS Foundation Trust, National Heart and Lung Institute, The Winnicott Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Composition of Bacteria Present, Established by Ultra-deep RNA Gene Sequencing, in Pre-morbid Faecal Samples From Neonates With Necrotizing Enterocolitis and Late-onset Bacterial Sepsis.	Faecal samples were analysed using 16S rRNA gene sequencing to determine the bacterial content present in faecal samples collected from pre term infants prior to the onset of necrotising enterocolitis.; Bacteria were identified and relative proportions reported for each faecal sample analysed.	Maximum of 6 months - serial samples collected from each infant (maximum admission duration 6 months), recruitment opened for 24 months.