The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales

Conditions
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Gastrointestinal Diseases

Intervention / Treatment
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* Dietary Supplement: Infant Formula with a novel probiotic CECT7210
* Dietary Supplement: Standard formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Formula<br>Infant formula with a novel probiotic CECT7210 | Dietary Supplement: Infant Formula with a novel probiotic CECT7210<br>* Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.<br>|
| Active Comparator: Standard Formula<br>Standard infant formula without probiotics | Dietary Supplement: Standard formula<br>* Standard formula without probiotics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in diarrhea incidence | Differences between diarrhea incidence amongst groups from baseline to 12th weeks. | At 4th, 8th, 12th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in infections incidence | Differences between rate of infections or duration amongst groups. | At 4th, 8th, 12th weeks. | 
| Changes in microbiota | Differences between faecal bacterial populations. | At 4th, 8th, 12th weeks | 
| Changes in Immunoglobulin A secretor (IgAs) | Differences between faecal IgAs amongst groups. | At 4th and 12th weeks | 
| Tolerability of the product | To evaluate gastrointestinal tolerability of both study formulas. | At 4th, 8th and 12th weeks | 
| Growth | To compare anthropometric measurements between probiotic CECT7210 formula group and standard group. | At 4th, 8th and 12th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Infant Formula, Microbiota, Bifidobacterium longum biovar infantis CECT7210, Growth