Trial | NCT02096302  Report issue

Title

The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health
Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    bifidobacterium longum ...

  • Study Participants

    194
The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.
This a multicenter, controlled, randomized, prospective, parallel, double-blinded study to evaluate the effect of an infant formula containing a new probiotic, Bifidobacterium longum biovar infantis CECT7210, on the incidence of diarrhea in healthy infants born at term. Infants will be randomized to take an standard infant formula or the infant formula with the probiotic CECT7210 during 12 weeks.
Study Started
Jan 31
2011
Primary Completion
Nov 30
2012
Study Completion
Jun 30
2013
Last Update
Jul 19
2019

Dietary Supplement Infant Formula with a novel probiotic CECT7210

Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.

Dietary Supplement Standard formula

Standard formula without probiotics

Experimental Formula Experimental

Infant formula with a novel probiotic CECT7210

Standard Formula Active Comparator

Standard infant formula without probiotics

Criteria 

Inclusion Criteria:

Full-term healthy newborns (>= 37 weeks)
Birth weight between >=2.500g and <=4.500g)
Normal growth curve (between 3-97 percentiles)
0-60 days of age on enrolment
Maximum 30 days of breastfeeding
Exclusively infant formula on enrolment
Breastfeeding or infant formula with pre/probiotics feeding stopped 15 days before enrolment
Parents or caregivers agree to exclude any source of prebiotics or probiotics during the study
Parents or caregivers agree to follow-on the study 12 weeks
Informed consent signed ( Parent/Legal representative)

Exclusion Criteria:

Congenital illness or malformation that may affect infant feeding and /or normal growth
Significant pre-natal or post-natal diseases
Infant's family history of atopy
Any pathology related to the immune or gastrointestinal system.
Suspected or known allergy to cow's milk protein
Infants receiving pre or probiotics within less than 15 days prior to enrolment
Infant's family who in the investigator's assessment cannot be expected to comply with the protocol
No Results Posted