Interactions between diet and gut microbes in preterm infants (INDIGO)
Research type
Research Study
Full title
Interactions between the diet and gut microbes and metabolism in preterm infants (INDIGO study).
IRAS ID
215037
Contact name
Nicholas D Embleton
Contact email
Sponsor organisation
Newcastle Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
Around 10% of babies are premature (born <37 weeks), but feeding them is complex. Mothers own breast-milk (MOM) is best and results in better outcomes e.g. less infections, but many mothers do not produce enough milk so either donor human milk (DHM) or a cow's milk derived formula is used to make up the 'shortfall'. Current feeding practices in the UK vary as there is no clear evidence which is best, but both MOM and DHM require fortification with additional nutrients in order to support optimal growth. This currently requires the use of a‘fortifier’ derived from cow’s milk, but new milk supplements made only from donor human milk are now used in US and Europe.
The pattern of gut bacteria in early life is associated with outcomes including infections and allergy, and this is especially important in preterm infants. Gut microbe patterns are determined by feeding but most studies are observational. Randomised trials of diet will improve understanding of how gut bacterial patterns relate to milk diet, and whether this also affects growth and body composition (fat mass and lean body mass).
This randomised study will compare two dietary regimens in very preterm infants and study the effect on the pattern of gut bacteria and chemicals (metabolites)in the stool and urine, as well as growth and body composition. To make up any shortfall in MOM the standard diet group will receive a cow's milk formula designed for preterm babies, and the intervention group will receive DHM. In addition, the fortifier used in the standard arm will be be derived from cow's milk and in the intervention group will be derived from human milk. Stool and urine samples will be collected to look at patterns of gut microbes and metabolites, and body composition will be measured using whole body magnetic resonance imaging (MRI).
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0169
Date of REC Opinion
29 Jun 2017
REC opinion
Further Information Favourable Opinion