The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health (GO-INF)

Laboratorios Ordesa

Status: Completed

Conditions: Gastrointestinal Diseases

Treatments: Dietary Supplement: Infant Formula with a novel probiotic CECT7210; Dietary Supplement: Standard formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02096302

GO-INF-010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 194 patients

Sex: All

Ages: Under 90 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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194 participants in 2 patient groups

Experimental Formula

Experimental group

Description:

Infant formula with a novel probiotic CECT7210

Treatment:

Dietary Supplement: Infant Formula with a novel probiotic CECT7210

Standard Formula

Active Comparator group

Description:

Standard infant formula without probiotics

Treatment:

Dietary Supplement: Standard formula