Color Synbiotics Study

Danone

Status: Completed

Conditions: Beneficial Bacteria in Gut

Treatments: Other: Regular non-hydrolysed cow's milk II; Other: Regular non-hydrolysed cow's milk I; Other: Regular non-hydrolysed cow's milk - control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813175

COL.1.C.A

Details and patient eligibility

About

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

Enrollment: 290 patients

Sex: All

Ages: 43 to 65 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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290 participants in 4 patient groups, including a placebo group

Intervention Group I

Active Comparator group

Description:

Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I

Treatment:

Other: Regular non-hydrolysed cow's milk I

Interventional Group II

Active Comparator group

Description:

Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II

Treatment:

Other: Regular non-hydrolysed cow's milk II

Control Group

Placebo Comparator group

Description:

Regular non-hydrolysed cow's milk based infant formula

Treatment:

Other: Regular non-hydrolysed cow's milk - control

Reference Group

No Intervention group

Description:

Exclusively breast-fed infants