Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants
NCT ID: NCT05303077
Last Updated: 2022-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2019-02-11
2020-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Study Infant Formula
Infant formula supplemented with omega 3 fatty acids and inactive Bifidobacteria
Nutribén Innova® 1
Infants are fed solely with infant formula supplemented with an inactive probiotic and omega 3 fatty acids over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's
Infant Formula
Infant formula
Nutribén®
Infants are fed solely with infant formula over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's age.
Breastfeed Active comparator
Infants who are breastfed
Breastfeed
Infants are breastfeeding solely over the first 6 months of their life, from then on the infants are fed as recommended by their caregiver, as if they are not participating in a research study.
Interventions
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Nutribén Innova® 1
Infants are fed solely with infant formula supplemented with an inactive probiotic and omega 3 fatty acids over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's
Nutribén®
Infants are fed solely with infant formula over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's age.
Breastfeed
Infants are breastfeeding solely over the first 6 months of their life, from then on the infants are fed as recommended by their caregiver, as if they are not participating in a research study.
Eligibility Criteria
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Inclusion Criteria
* Full term infants (between 37 and 42 weeks of pregnancy).
* Birth weight between 2500 g- 4500 g.
* Single birth babies.
* BMI of the mothers before the pregnancy between 19 y 30 kg/m2.
Exclusion Criteria
* Cow's milk protein allergy and/or lactose allergy.
* Administration of antibiotics 7 days prior inclusion.
* Congenital disease or malformation that may affect the infant growth rate.
Population Description: The study population are newborns selected from primary care clinics in Spain.
Sampling Method: Not applicable
* Metabolic disease or disorders.
* Significant prenatal disease and/or serious postnatal disease before recruitment.
* Underage parents.
* Diabetic mother.
* Born from a drug abuse mother (who use abuse drugs during pregnancy).
* Parents cannot comply with study procedures.
* Subject included or that have been included in other clinical trial since his/her birth day.
15 Days
25 Days
ALL
Yes
Sponsors
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Fundación Teófilo Hernando, Spain
OTHER
Biopolis S.L.
INDUSTRY
Alter Farmacia, S.A.
INDUSTRY
Responsible Party
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Locations
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Cap Montclar
Barcelona, , Spain
Cap Nova Lloreda
Barcelona, , Spain
Cap Sant Ildefons
Barcelona, , Spain
Consulta Dr. Xavier Riopedre
Barcelona, , Spain
Consulta Carlos Nuñez de Prado Aparicio
Madrid, , Spain
Consultorio Arroyomolinos (Cs Parque Coimbra)
Madrid, , Spain
Cs Alcalde Bartolomé Gonzalez Móstoles
Madrid, , Spain
Cs Conde de Barcelona
Madrid, , Spain
Cs Dr Luengo Rodríguez
Madrid, , Spain
Cs Infante Don Luis de Borbón
Madrid, , Spain
Cs La Rivota
Madrid, , Spain
Cs Las Américas
Madrid, , Spain
Cs Miguel Servet
Madrid, , Spain
Cs Parque Loranca
Madrid, , Spain
Cs Presentación Sabio
Madrid, , Spain
Cs Valle de La Oliva
Madrid, , Spain
Clínica Dr Aguilar-Dr Sacristán
Seville, , Spain
Consultas Externas Hospital Privado Santa Ángela de La Cruz
Seville, , Spain
Cs Amante Laffón
Seville, , Spain
Cs Utrera Norte
Seville, , Spain
Ihp Bellavista
Seville, , Spain
Countries
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Other Identifiers
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INNOVA 2020
Identifier Type: -
Identifier Source: org_study_id
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