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

Danone Asia Pacific Holdings Pte, Ltd.3 sites in 1 country290 target enrollmentMay 2013

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Beneficial Bacteria in Gut
Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Enrollment: 290
Locations: 3
Primary Endpoint: Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group
Status: Completed
Last Updated: 8 years ago

This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

July 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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 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

Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group

Time Frame: baseline, week 6

Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group(baseline, week 6)
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group(baseline, week 6)