Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants
The Effect of a New Newborn Formula Over the Corporal Composition: a Randomized Multicentric Clinical Trial
1 other identifier
interventional
210
1 country
21
Brief Summary
This is a multicentric, randomized, blinded, controlled trial to study the effects of a new infant formula on the changes in the newborn body composition over time: weight gain, anthropometric data, incidence of infections, digestive tolerance (flatulence, vomiting and regurgitation), feces (consistency and frequency), behavior (restlessness, colic, nocturnal awakenings), count of probiotic strains of the intestinal microbiota in feces, safety and tolerability of the investigational products (measured as number, frequency and severity of adverse events in all branches of the study)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Feb 2019
Typical duration for not_applicable healthy
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2020
CompletedFirst Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedApril 7, 2022
March 1, 2022
1.8 years
March 21, 2022
March 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight gain at 6 months
Measure of weight gain by grams/day between the first visit and month 6
6 months after the beginning of the study
Secondary Outcomes (18)
weight at 21 days, 2, 4, 6 and 12 months
21 days, 2, 4, 6 and 12 months
Length gain
21 days, 2, 4, 6 and 12 months
Head circumference gain
21 days, 2, 4, 6 and 12 months
Tricipital Skin fold development
4, 6 and 12 months
Subscapular skin fold develompent
4, 6 and 12 months
- +13 more secondary outcomes
Study Arms (3)
Study Infant Formula
EXPERIMENTALInfant formula supplemented with omega 3 fatty acids and inactive Bifidobacteria
Infant Formula
ACTIVE COMPARATORInfant formula
Breastfeed Active comparator
ACTIVE COMPARATORInfants who are breastfed
Interventions
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
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.
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
You may qualify if:
- Healthy children. Both sex.
- 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.
You may not qualify if:
- Body weight lower than the 5th percentile for their gestational age.
- Cow's milk protein allergy and/or lactose allergy.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alter Farmacia, S.A.lead
- Fundación Teófilo Hernando, Spaincollaborator
- Biopolis S.L.collaborator
Study Sites (21)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The 2 infant formula arms are blinded for the participant, investigator and data analyst. The 3rd arm is an open control group conformed by breastfeed infants
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2022
First Posted
March 31, 2022
Study Start
February 11, 2019
Primary Completion
November 25, 2020
Study Completion
November 25, 2020
Last Updated
April 7, 2022
Record last verified: 2022-03