The activity of the premature gut
Research type
Research Study
Full title
Early newborn care practices and the development and functionality of the human microbiome
IRAS ID
192563
Contact name
Neena Modi
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Premature babies (babies born before their due date), are at particular risk of serious illnesses such as infection that can lead to permanent damage or death. One of the key defences are the bacteria (microbes) in the gut. Preterm babies are often exposed to different medical treatments which can result in a gut imbalance of good and bad bacteria. These bad bacteria push essential bacteria out, cause illness and produce chemicals that cause significant damage. This study will assess the proportion of good and bad bacteria in the gut and the chemicals they produce that cause illness in preterm babies. This is clinically relevant as new-born infections can have mortality rates of up to 40%.
The primary focus of this study will be on the role of a specific group of chemicals produced by gut bacteria known as proteases. Proteases are important for growth and in keeping the gut healthy. When the gut contains bacteria which produce too many proteases, this increases the chance of infection. The ultimate aim is to measure protease activity in the gut of preterm babies.
The proposed study will be a long-term follow-up of protease activity in infants aged between 24-32 weeks. Patient’s will be identified and recruited from the Chelsea and Westminster neonatal unit. Every infant <32 weeks’ gestation is eligible and unless opt-out consent is given one stool sample per day will be collected from the infants’ nappy. Amounts of protease, type of protease and origin of proteases will be measured in these samples. Additionally, the study will assess if the amount of proteases changes over time spent in the neonatal unit and whether babies who developed infection had; 1) different types of proteases and 2) higher levels of proteases. Planned recruitment and sample collection processes are to cover a 1-year period.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0973
Date of REC Opinion
16 Jun 2016
REC opinion
Favourable Opinion