Clinical trial NCT02096302: The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health
Official title: Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Diseases
Keywords: Probiotics
Infant Formula
Microbiota
Bifidobacterium longum biovar infantis CECT7210
Growth
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
Collaborators: name: Harrison Clinical Research
First posted: 2014-03-26
Enrollment: 194
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Changes in diarrhea incidence
timeFrame: At 4th, 8th, 12th weeks
Secondary outcomes:
measure: Changes in infections incidence
timeFrame: At 4th, 8th, 12th weeks.
measure: Changes in microbiota
timeFrame: At 4th, 8th, 12th weeks
measure: Changes in Immunoglobulin A secretor (IgAs)
timeFrame: At 4th and 12th weeks
measure: Tolerability of the product
timeFrame: At 4th, 8th and 12th weeks
measure: Growth
timeFrame: At 4th, 8th and 12th weeks
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hospital Sant Joan de Reus
state: Tarragona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
Study officials:
affiliation: Hospital Universitario La Paz
name: Isabel Polanco, Professor
role: STUDY_CHAIR
affiliation: Hospital Sant Joan de Reus, Reus, Spain
name: Joaquin Escribano, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Joan XXIII de Tarragona, Tarragona, Spain
name: Ricardo Closa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Closa R, Ferré N, Luque V, Gispert-Llaurado M, Ruibio-Torrents C, Polanco I, Morera M, Moreno JA, Rivero M, Escribano J. Effect of probiotic CECT7210 supplementation of infant formula in healthy infants. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PA-N-0038.
citation: Moreno JA, Cifuentes GC, Morera M, Martínez-Blach JF, Codoñer F, Genovés S, Chenoll E, Polanco I, Closa R, Escribano J, Ferré N, Luque V, Rivero M. Feeding infant formula supplemented with the probiotic bacteria bifidobacterium longum subsp.infantis CECT7210 produce beneficial changes in gastointestinal microbial communities: a metagenomic approach. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PO-N-0361.