Gastrointestinal Diseases
Conditions
Keywords
Probiotics, Infant Formula, Microbiota, Bifidobacterium longum biovar infantis CECT7210, Growth
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.
Interventions
DIETARY_SUPPLEMENTInfant 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_SUPPLEMENTStandard formula
Standard formula without probiotics
Sponsors
Harrison Clinical Research
Laboratorios Ordesa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in diarrhea incidence | At 4th, 8th, 12th weeks | Differences between diarrhea incidence amongst groups from baseline to 12th weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in infections incidence | At 4th, 8th, 12th weeks. | Differences between rate of infections or duration amongst groups. |
| Changes in microbiota | At 4th, 8th, 12th weeks | Differences between faecal bacterial populations. |
| Changes in Immunoglobulin A secretor (IgAs) | At 4th and 12th weeks | Differences between faecal IgAs amongst groups. |
| Tolerability of the product | At 4th, 8th and 12th weeks | To evaluate gastrointestinal tolerability of both study formulas. |
| Growth | At 4th, 8th and 12th weeks | To compare anthropometric measurements between probiotic CECT7210 formula group and standard group. |
Countries
Spain
Outcome results
None listed