Defining the Intestinal Microbiota in Premature Neonates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Winnicott Foundation
National Heart and Lung Institute
Chelsea and Westminster NHS Foundation Trust
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01102738
First received: March 31, 2010
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

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.

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.

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.


Condition
Premature Intestinal Microbiota
Necrotizing Enterocolitis
Late Onset Bloodstream Infection

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Microbiota of the Premature Neonatal Gastrointestinal Tract: Its Development and Relation to Necrotizing Enterocolitis and Bloodstream Infection

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • The sum total of all bacteria present, established by ultra-deep RNA gene sequencing, in pre-morbid faecal samples from neonates with necrotizing enterocolitis and late-onset bacterial sepsis. [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Faecal samples, surplus gut tissue samples (if patient requires bowel resection due to Necrotizing Enterocolitis).


Estimated Enrollment: 360
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Premature babies (<32 weeks)
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.

  Eligibility

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Premature babies born at less than 32 completed weeks gestation

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102738

Contacts
Contact: J Simon Kroll s.kroll@imperial.ac.uk
Contact: Kathleen Sim k.sim@imperial.ac.uk

Locations
United Kingdom
St. Mary's Hospital - Winnicott Baby Unit Recruiting
London, United Kingdom
Contact: Kathleen Sim       k.sim@imperial.ac.uk   
Sub-Investigator: Peter Chow         
Queen Charlotte's and Chelsea Hospital - NICU Recruiting
London, United Kingdom
Contact: Kathleen Sim       k.sim@imperial.ac.uk   
Sub-Investigator: David Edwards         
Imperial College London Not yet recruiting
London, United Kingdom, W21PG
Principal Investigator: J Simon Kroll         
Sponsors and Collaborators
Imperial College London
The Winnicott Foundation
National Heart and Lung Institute
Chelsea and Westminster NHS Foundation Trust
Investigators
Principal Investigator: J Simon Kroll, MA BM FRCP Imperial College London
  More Information

No publications provided

Responsible Party: Prof Simon Kroll, Imperial College London
ClinicalTrials.gov Identifier: NCT01102738     History of Changes
Other Study ID Numbers: CR01542
Study First Received: March 31, 2010
Last Updated: February 28, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Infection
Communicable Diseases
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 22, 2014