Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 194
- Locations
- 3
- Primary Endpoint
- Changes in diarrhea incidence
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 90 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Experimental Formula
Infant formula with a novel probiotic CECT7210
Intervention: Infant Formula with a novel probiotic CECT7210 (Dietary Supplement)
Standard Formula
Standard infant formula without probiotics
Intervention: Standard formula (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in diarrhea incidence
Time Frame: At 4th, 8th, 12th weeks
Differences between diarrhea incidence amongst groups from baseline to 12th weeks.
Secondary Outcomes
- Changes in infections incidence(At 4th, 8th, 12th weeks.)
- Tolerability of the product(At 4th, 8th and 12th weeks)
- Changes in microbiota(At 4th, 8th, 12th weeks)
- Changes in Immunoglobulin A secretor (IgAs)(At 4th and 12th weeks)
- Growth(At 4th, 8th and 12th weeks)