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Completed

NCT Number: NCT05303077

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

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)

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Key information

Conditions

Healthy

Age range

15 day–25 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cap Montclar, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutribén Innova® 1

Dietary Supplement

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®

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Weight gain at 6 months

    Time frame: 6 months after the beginning of the study

    Measure of weight gain by grams/day between the first visit and month 6

Secondary outcomes

  1. weight at 21 days, 2, 4, 6 and 12 months

    Time frame: 21 days, 2, 4, 6 and 12 months

    Measure of weight gain by grams

  2. Length gain

    Time frame: 21 days, 2, 4, 6 and 12 months

    Measure of the infant's length gain over time in cms

  3. Head circumference gain

    Time frame: 21 days, 2, 4, 6 and 12 months

    Measure of the increase of the head circumference over time in cms

  4. Tricipital Skin fold development

    Time frame: 4, 6 and 12 months

    Measurement of the development of tricipital skin fold, in cms, measured using a skinfold caliper

  5. Subscapular skin fold develompent

    Time frame: 4, 6 and 12 months

    Measurement of the development of subscapular skin fold, in cms, measured using a skinfold caliper

  6. Mean arm circumference

    Time frame: 4, 6 and 12 months

    Measure of arm circumference over time in cms.

  7. Feces features consistency

    Time frame: 21 days, 2, 4, 6 and 12 months

    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.

  8. Feces features number of bowel movements

    Time frame: 21 days, 2, 4, 6 and 12 months

    Number of bowel movements per day sorted by study group

  9. Digestive tolerance

    Time frame: 4, 6 and 12 months

    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.

  10. Infant's behavior

    Time frame: 4, 6 and 12 months

    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.

  11. intestinal microbiota

    Time frame: 4, 6 and 12 months

    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.

  12. Evolution of calprotectin levels in feces

    Time frame: 21 days, 2, 6 and 12 months

    Measurement of the evolution of calprotectin levels in feces over time

  13. Evolution of IgA levels in feces

    Time frame: 21 days, 2, 6 and 12 months

    Measurement of the evolution of IgA levels in feces over time

  14. Evolution lactic acid levels in feces

    Time frame: 21 days, 2, 6 and 12 months

    Measurement of the evolution of lactic acid levels in feces over time

  15. Evolution of short-chain fatty acid levels in feces

    Time frame: 21 days, 2, 6 and 12 months

    Measurement of the evolution of short-chain fatty acid levels in feces over time

  16. Morbility

    Time frame: over a year

    Analysis of the number and frequency of all adverse events registered during the study by feeding group

  17. Products Tolerability

    Time frame: over a year

    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.

  18. Overall rate of the products

    Time frame: 2, 4, 6 and 12 months

    Quantitative variable. The parents' subjective rate of the products. The assessment can be, acceptable, good, very good, satisfactory or not satisfactory.

Sponsors and collaborators

Lead sponsor

Alter Farmacia, S.A.

Industry

Collaborators

  • Biopolis S.L.
  • Fundación Teófilo Hernando, Spain

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2022
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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