Cinnamon - Infant milk formula with two Human Milk Oligosaccharides
Research type
Research Study
Full title
Clinical safety & efficacy of a new infant formula with specific medical purpose (FSMP) containing 2 human milk oligosaccharides (HMOs)
IRAS ID
213544
Contact name
Ralf Hartung
Contact email
Sponsor organisation
Nestec
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is a double blind, randomised controlled trial to establish the safety and efficacy of a new infant formula with a specific medical purpose (FSMP) which contains two human milk oligosaccharides (HMOs). The patient population will consist of infants with cow’s milk protein allergy aged 0 to 6 months at enrolment. Up to 175 infants will be recruited globally ensuring evaluable data is available for 130 participants.
Many studies have shown that breastfed infants exhibit a lower incidence of infection when compared to formula fed infants, in part this could be due to the differences in gut bacteria between breastfed and formula fed infants. An important group of molecules are the milk oligosaccharides (OS); these are short chains of sugars present in the milk of mammals that act as prebiotics (natural compounds that help with the establishment of beneficial gut bacteria).
The relative amounts of the various OS present in milk between species differ, however standard infant formulas make no provision for the inclusion of HMOs which could reduce infections through prebiotic action and preventing pathogen attachment in the gut. Moreover traditional formulas have been designed for infants who are very unwell and contain more protein than is needed by infants with cow’s milk protein allergy, sometimes up to 80% higher; the study formula is more aligned with protein levels in human breast milk.
Once screened and enrolled patients will be randomised into two groups, one taking the study formula (Althéra 2.2 with HMOs), and the other taking the control formula (Althéra 2.5). All participating infant’s growth and stool characteristics will be assessed until they reach 12 months of age. Some sites will also collect urine and stool samples at visits 0, 1, 4 and 6 to assess the gut bacteria and metabolic signature to achieve the secondary exploratory objectives.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0012
Date of REC Opinion
24 Feb 2017
REC opinion
Further Information Favourable Opinion