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Defining the Intestinal Microbiota in Premature Neonates

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ClinicalTrials.gov Identifier: NCT01102738
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborators:
The Winnicott Foundation
National Heart and Lung Institute
Chelsea and Westminster NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London

Brief 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.

Condition or disease
Premature Intestinal Microbiota Necrotizing Enterocolitis Late Onset Bloodstream Infection

Detailed 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.

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Study Type : Observational
Actual Enrollment : 369 participants
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
Actual Study Start Date : January 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
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.



Primary Outcome Measures :
  1. 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. [ Time Frame: Maximum of 6 months - serial samples collected from each infant (maximum admission duration 6 months), recruitment opened for 24 months. ]

    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.



Biospecimen Retention:   Samples Without DNA
Faecal samples, surplus gut tissue samples (if patient requires bowel resection due to Necrotizing Enterocolitis).


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
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
Sponsors and Collaborators
Imperial College London
The Winnicott Foundation
National Heart and Lung Institute
Chelsea and Westminster NHS Foundation Trust
Investigators
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Principal Investigator: J Simon Kroll, MA BM FRCP Imperial College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01102738    
Other Study ID Numbers: CR01542
First Posted: April 13, 2010    Key Record Dates
Results First Posted: May 1, 2020
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Premature intestinal microbiota
Necrotizing Enterocolitis
Additional relevant MeSH terms:
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Infection
Sepsis
Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes