Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Synbiotics Mixtures on Gut Microbiota Composition in Healthy Infants.

Study start date: May 1, 2013

Inclusion Criteria: Healthy term infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) aged 46 - 65 days (inclusive) at entry into the study Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study) Parents' or legal guardian's written informed consent Exclusion Criteria: Exclusion criteria for run-in period (visit 1, screening) are: Being weaned before inclusion (introduction of any other foods other than formula or human milk) Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards Medical condition for which a special diet other than standard (non hydrolised) cow's milk-based infant formula is required Known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks prior to entry into the study Received Inactivated Poliovirus Vaccine (IPV) or Rotavirus Vaccine (RV) prior to entry into the study Gastroenteritis or diarrhoea in the last two weeks prior to entry into the study Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements