Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants

Healthy Clinical Trial

Official title:

The Effect of a New Newborn Formula Over the Corporal Composition: a Randomized Multicentric Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05303077
• Other study ID #: INNOVA 2020
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: November 25, 2020

Study information

• Verified date: March 2022
• Source: Alter Farmacia, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 25 Days

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Spain	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	Sevilla
Spain	Consultas Externas Hospital Privado Santa Ángela de La Cruz	Sevilla
Spain	Cs Amante Laffón	Sevilla
Spain	Cs Utrera Norte	Sevilla
Spain	Ihp Bellavista	Sevilla

Sponsors (3)

Lead Sponsor	Collaborator
Alter Farmacia, S.A.	Biopolis S.L., Fundación Teófilo Hernando, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	weight at 21 days, 2, 4, 6 and 12 months	Measure of weight gain by grams	21 days, 2, 4, 6 and 12 months
Secondary	Length gain	Measure of the infant's length gain over time in cms	21 days, 2, 4, 6 and 12 months
Secondary	Head circumference gain	Measure of the increase of the head circumference over time in cms	21 days, 2, 4, 6 and 12 months
Secondary	Tricipital Skin fold development	Measurement of the development of tricipital skin fold, in cms, measured using a skinfold caliper	4, 6 and 12 months
Secondary	Subscapular skin fold develompent	Measurement of the development of subscapular skin fold, in cms, measured using a skinfold caliper	4, 6 and 12 months
Secondary	Mean arm circumference	Measure of arm circumference over time in cms.	4, 6 and 12 months
Secondary	Feces features consistency	Description of the consistency of baby's feces features, according to their parent's perception, on a qualitative scale: soft, hard, liquid, normal, semiliquid, pasty. The analysis includes the number of feces in each group and the overall frequency by study arm and visit.	21 days, 2, 4, 6 and 12 months
Secondary	Feces features number of bowel movements	Number of bowel movements per day sorted by study group	21 days, 2, 4, 6 and 12 months
Secondary	Digestive tolerance	The digestive tolerance will be assessed as adequate, constipation, flatulence, vomit or other distresses, which are a heterogeneous group that includes various affections as diarrhea, abdominal pain, irritability, constipation, regurgitation or colic. The analysis includes the overall number and the frequency sorted by study arm.	4, 6 and 12 months
Secondary	Infant's behavior	Qualitative variable. The infant's behavior is classified as either good or altered. The total number and the relative frequency by group are included in the analysis.	4, 6 and 12 months
Secondary	intestinal microbiota	Analysis of the evolution of the intestinal microbiota of the children over the study. The richness and diversity of the microbiota are analyzed and compared between the study groups.	4, 6 and 12 months
Secondary	Evolution of calprotectin levels in feces	Measurement of the evolution of calprotectin levels in feces over time	21 days, 2, 6 and 12 months
Secondary	Evolution of IgA levels in feces	Measurement of the evolution of IgA levels in feces over time	21 days, 2, 6 and 12 months
Secondary	Evolution lactic acid levels in feces	Measurement of the evolution of lactic acid levels in feces over time	21 days, 2, 6 and 12 months
Secondary	Evolution of short-chain fatty acid levels in feces	Measurement of the evolution of short-chain fatty acid levels in feces over time	21 days, 2, 6 and 12 months
Secondary	Morbility	Analysis of the number and frequency of all adverse events registered during the study by feeding group	over a year
Secondary	Products Tolerability	Quantitative variable. The tolerability of the products is assessed as adequate, good, very good, unsatisfactory. The analysis includes the overall number y and the relative frequency by group.	over a year
Secondary	Overall rate of the products	Quantitative variable. The parents' subjective rate of the products. The assessment can be, acceptable, good, very good, satisfactory or not satisfactory.	2, 4, 6 and 12 months