Colonisation Resistance Study (ColoR)

Danone

Status and phase: Withdrawn; Phase 2

Conditions: Healthy Infants

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01507935

COL.1.C/A

Details and patient eligibility

About

This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.

Sex: All

Ages: 8 to 10 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion
• 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 guardian's written informed consent

Exclusion criteria

• Being weaned before inclusion (introduction of any other foods other than formula or breast milk.)
• Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
• Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps)
• Significant congenital abnormality that could affect the study results
• Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study
• Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
• Gastroenteritis in the last two weeks before inclusion

Trial design

0 participants in 4 patient groups, including a placebo group

Intervention Group I

Active Comparator group

Description:

Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I

Treatment:

Other: Regular non-hydrolysed cow's milk

Other: Regular non-hydrolysed cow's milk

Other: Regular non-hydrolysed cow's milk

Intervention Group II

Active Comparator group

Description:

Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II

Treatment:

Other: Regular non-hydrolysed cow's milk

Other: Regular non-hydrolysed cow's milk

Other: Regular non-hydrolysed cow's milk

Control Group

Placebo Comparator group

Description:

Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides

Treatment:

Other: Regular non-hydrolysed cow's milk

Other: Regular non-hydrolysed cow's milk

Other: Regular non-hydrolysed cow's milk

Reference group

No Intervention group

Description:

Exclusively breast-fed infants