Colonisation Resistance Study (ColoR)

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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Withdrawn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
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
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
Reference group
No Intervention group
Description:
Exclusively breast-fed infants

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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