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OpenTrials
Completed

NCT Number: NCT01880970

Effect of Starter Formula on Infection Prevention

The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.

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Key information

Conditions

Gastro-intestinal Infections Infections With Fever

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Croix Rousse, Service de réanimation néonatale, Lyon, France

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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 newborn infant
  • Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
  • Age of infant is ≤ 13 days at the time of enrollment
  • Birth weight ≥ 2500g and ≤ 4500g
  • For the FF groups: The infant's mother has elected not to breastfeed
  • For the BF group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
  • Having obtained his/her legal representative's informed consent

Exclusion criteria

  • Congenital illness or malformation that may affect normal growth (especially immunodeficiencies)
  • Significant pre-natal and/or post-natal diseases
  • Perinatal antibiotic or infants on antibiotics at the time of inclusion
  • Infants whose mother has had an acute infection during the last month of pregnancy
  • Re-hospitalisation for more than 2 days in the first 14 days of life (exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study)
  • Receiving infant formula containing probiotics and/or prebiotics at the time of enrollment
  • Newborn whose parents / caregivers cannot be expected to comply with treatment
  • Newborn currently participating in another interventional clinical trial

Treatment and study plan

starter infant formula with pro and prebiotics

Other

Placebo Comparator

Other

Primary outcomes

  1. Diarrhea and all infections with fever

    Time frame: over 6 months and 1 year

    Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year

Secondary outcomes

  1. Morbidity

    Time frame: over 6 months and 1 year

    Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year

  2. Anthropometry

    Time frame: until 1 year

    Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold)

  3. Digestive tolerance

    Time frame: until 1 year

    Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)

  4. Stool characteristics

    Time frame: at 3 and 6 months

    • Stool bacterial populations (Bifidobacteria, Lactobacilli Species, Clostridium, Bacteroides, Staphylococci epidermitis, presence or absence of B. lactis)
    • Stool pH
    • Stool and saliva S.IgA
    • Stool Alpha 1-antitrypsine as infection/inflammation marker

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 19, 2013
Registry last updated
Oct 21, 2015

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.