Synbiotics and Growth
Synbiotics and Growth
The primary objective of the trial is to assess the growth of the infants enrolled into the
 study. Other parameters to be measured include microbiota balance and certain blood
 biochemical values. In addition the infants' digestive tolerance of the formulae and
 frequency of morbidity will be investigated.
The infants will be recruited between birth and 14 days of life and will start on the
 allocated study formula as soon as they are enrolled. In practice this will tend to be
 immediately after birth. The treatment period, in terms of data necessary for the primary
 outcome, will be until they reach 16 weeks old. Growth and other measurements will be
 collected on five separate occasions during this period, ie 2, 4, 8, 12 and 16 weeks of life.
 Although the study intervention formally ends at 16 weeks, it will be useful to have a follow
 up visit at 26 weeks to collect further data on the gut microflora in the sub-group of
 infants who have already provided a stool sample at 8 weeks. This follow-up visit will be of
 benefit to the subject as they receive a weight check and clinical examination by a
 paediatrician and will be offered to all subjects (no invasive procedures will be carried
 out).
Inclusion Criteria:

 -  Healthy new-born infant

 -  Infant is less14 days old on day of enrollment

 -  Birthweight between 2500g and 4500g

 -  Gestational age over 37 weeks

 -  Singleton birth

 -  Infant's mother, before the 14th day of the child's life, has elected not to
 breastfeed

 -  Infant randomized in to a treatment group can expected to be exclusively fed the
 formula from enrolment until 16 weeks old

 -  Having obtained his/her legal representative's informed consent

 Exclusion Criteria:

 -  Currently participating in another clinical trial

 -  Congenital illness or malformation that may affect normal growth

 -  Significant pre-natal and/or post-natal disease

 -  Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally,
 infants re-hospitalized because of jaundice may be enrolled in the study).

 -  Receiving antibiotic treatment at time of enrolment or in the 5 previous days.

 -  Receiving infant formula containing probiotics and/or prebiotics at the time of
 enrolment