Defining the Intestinal Microbiota in Premature Neonates
|ClinicalTrials.gov Identifier: NCT01102738|
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : March 26, 2015
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 or disease|
|Premature Intestinal Microbiota Necrotizing Enterocolitis Late Onset Bloodstream Infection|
|Study Type :||Observational|
|Actual Enrollment :||369 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||The Microbiota of the Premature Neonatal Gastrointestinal Tract: Its Development and Relation to Necrotizing Enterocolitis and Bloodstream Infection|
|Study Start Date :||January 2011|
|Primary Completion Date :||January 2013|
|Study Completion Date :||June 2014|
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.
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102738
|Imperial College London|
|London, United Kingdom, W21PG|
|Queen Charlotte's and Chelsea Hospital - NICU|
|London, United Kingdom|
|St. Mary's Hospital - Winnicott Baby Unit|
|London, United Kingdom|
|Principal Investigator:||J Simon Kroll, MA BM FRCP||Imperial College London|