Clinical trial NCT05303077: Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants
Official title: The Effect of a New Newborn Formula Over the Corporal Composition: a Randomized Multicentric Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Infant formula, body composition, safety
Lead sponsor: Alter Farmacia, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Fundación Teófilo Hernando, Spain
name: Biopolis S.L.
First posted: 2022-03-31
Enrollment: 210
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Weight gain at 6 months
timeFrame: 6 months after the beginning of the study
Secondary outcomes:
measure: weight at 21 days, 2, 4, 6 and 12 months
timeFrame: 21 days, 2, 4, 6 and 12 months
measure: Length gain
timeFrame: 21 days, 2, 4, 6 and 12 months
measure: Head circumference gain
timeFrame: 21 days, 2, 4, 6 and 12 months
measure: Tricipital Skin fold development
timeFrame: 4, 6 and 12 months
measure: Subscapular skin fold develompent
timeFrame: 4, 6 and 12 months
measure: Mean arm circumference
timeFrame: 4, 6 and 12 months
measure: Feces features consistency
timeFrame: 21 days, 2, 4, 6 and 12 months
measure: Feces features number of bowel movements
timeFrame: 21 days, 2, 4, 6 and 12 months
measure: Digestive tolerance
timeFrame: 4, 6 and 12 months
measure: Infant's behavior
timeFrame: 4, 6 and 12 months
measure: intestinal microbiota
timeFrame: 4, 6 and 12 months
measure: Evolution of calprotectin levels in feces
timeFrame: 21 days, 2, 6 and 12 months
measure: Evolution of IgA levels in feces
timeFrame: 21 days, 2, 6 and 12 months
measure: Evolution lactic acid levels in feces
timeFrame: 21 days, 2, 6 and 12 months
measure: Evolution of short-chain fatty acid levels in feces
timeFrame: 21 days, 2, 6 and 12 months
measure: Morbility
timeFrame: over a year
measure: Products Tolerability
timeFrame: over a year
measure: Overall rate of the products
timeFrame: 2, 4, 6 and 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Cap Montclar
city: Barcelona
country: Spain
facility: Cap Nova Lloreda
city: Barcelona
country: Spain
facility: Cap Sant Ildefons
city: Barcelona
country: Spain
facility: Consulta Dr. Xavier Riopedre
city: Madrid
country: Spain
facility: Consulta Carlos Nuñez de Prado Aparicio
city: Madrid
country: Spain
facility: Consultorio Arroyomolinos (Cs Parque Coimbra)
city: Madrid
country: Spain
facility: Cs Alcalde Bartolomé Gonzalez Móstoles
city: Madrid
country: Spain
facility: Cs Conde de Barcelona
city: Madrid
country: Spain
facility: Cs Dr Luengo Rodríguez
city: Madrid
country: Spain
facility: Cs Infante Don Luis de Borbón
city: Madrid
country: Spain
facility: Cs La Rivota
city: Madrid
country: Spain
facility: Cs Las Américas
city: Madrid
country: Spain
facility: Cs Miguel Servet
city: Madrid
country: Spain
facility: Cs Parque Loranca
city: Madrid
country: Spain
facility: Cs Presentación Sabio
city: Madrid
country: Spain
facility: Cs Valle de La Oliva
city: Sevilla
country: Spain
facility: Clínica Dr Aguilar-Dr Sacristán
city: Sevilla
country: Spain
facility: Consultas Externas Hospital Privado Santa Ángela de La Cruz
city: Sevilla
country: Spain
facility: Cs Amante Laffón
city: Sevilla
country: Spain
facility: Cs Utrera Norte
city: Sevilla
country: Spain
facility: Ihp Bellavista
Study officials:
References: