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Completed

NCT Number: NCT03204630

Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota

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Key information

Conditions

Infant Nutrition

Age range

3 week–5 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Reina Sofía, Córdoba, 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

  • Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life.
  • Signature of informed parental or guardian consent.

Exclusion criteria

  • Allergic to the protein in cow's milk.
  • Lactose intolerant.
  • Suffering from a serious metabolic disease.
  • They have experienced or are experiencing some severe gastrointestinal disease.
  • Receive some form of chronic medication or are receiving antibiotics at the time of capture.
  • Low expectation of compliance with the study protocol.
  • allergic to any group of antibiotics.

Treatment and study plan

Lfer

Dietary Supplement

Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716

Bifido

Dietary Supplement

Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263

Control

Other

Standard infant formula

Primary outcomes

  1. Body weight gain

    Time frame: 12 months versus baseline

    Body weight gain at 12 months (grams)

Secondary outcomes

  1. Length

    Time frame: 1,2,4,6,9 and 12 months of age

    Length (cm)

  2. Body weight

    Time frame: 1,2,4,6,9 and 12 months of age

    Body weight of infants at different times (kg)

  3. Incidence of infections

    Time frame: total incidence during intervention (11 months)

    Events of infections diseases during intervention period (Incidence rate)

  4. Bacterial load in feces

    Time frame: 1,2,4,6,9 and 12 months of age

    Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces)

  5. Regurgitation

    Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age

    Measurement by score: 1 = not at all, 2 = regurgitation of small amounts during or shortly after feeding, 3 = larger regurgitation during or shortly after feeding, 4 = minor vomiting with time-lag to prior feeding, and 5 = severe vomiting with considerable loss of fluid.

  6. Fecal deposition

    Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age

    Measurement by score:1 = <1 time, 2 = 1-3, 3 = 4-6, 4 = 7-10, and 5 = >10.

  7. Infant colic

    Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age

    Average crying hours per day during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age. Score: no crying; < 3 hours/day; 3-6 hours/day; 6-12 hours/day; > 12 hours/day

  8. Flatulency

    Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age

    Average of duration of flatulence episodes (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score:no flatulency; < 3 hours/day; 3-6 hours/day; 6-12 hours/day; > 12 hours/day

  9. Hours of night sleep

    Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age

    Average of time of night sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: < 4 hours ; 4-6 hours; 6-9 hours; 9-12 hours; > 12 hours

  10. Total hours of sleep/day

    Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age

    Average of total time of sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: < 11 hours;  11-14 hours; 14-17 hours; 17-20 hours;  > 20 hours

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Collaborators

  • Andaluz Health Service
  • Maimónides Biomedical Research Institute of Córdoba

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jul 2, 2017
Registry last updated
Jul 2, 2017

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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