Status:
COMPLETED
Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants
Lead Sponsor:
Alter Farmacia, S.A.
Collaborating Sponsors:
Fundación Teófilo Hernando, Spain
Biopolis S.L.
Conditions:
Healthy
Eligibility:
All Genders
15-25 years
Phase:
NA
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, i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Body weight lower than the 5th percentile for their gestational age.
- 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.
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2020
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05303077
Start Date
February 11 2019
End Date
November 25 2020
Last Update
April 7 2022
Active Locations (21)
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1
Cap Montclar
Barcelona, Spain
2
Cap Nova Lloreda
Barcelona, Spain
3
Cap Sant Ildefons
Barcelona, Spain
4
Consulta Dr. Xavier Riopedre
Barcelona, Spain