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Effect of Starter Formula on Infection Prevention

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ClinicalTrials.gov Identifier: NCT01880970
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Nestlé

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

Condition or disease Intervention/treatment Phase
Gastro-intestinal Infections Infections With Fever Other: starter infant formula with pro and prebiotics Other: Placebo comparator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants
Study Start Date : October 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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Arm Intervention/treatment
Active Comparator: Starter infant formula with pro and prebiotics
starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age
Other: starter infant formula with pro and prebiotics
Placebo Comparator: starter infant formula without pro and prebiotics
starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age
Other: Placebo comparator
No Intervention: Breastfeeding group
exclusively breastfeeding during the first 3 months of age, followed by a commercially available Nestlé starter infant formula from 4 to 6 months of age (if applicable) and the follow-up infant formula from 6 to 12 months of age



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880970


Locations
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France
Hôpital de la Croix Rousse, Service de réanimation néonatale
Lyon, France, 69317
Hôpital Arnaud de Villeneuve, Service de pédiatrie 2
Montpellier, France, 34295
Maternité régionale de Nancy, Service de Néonatologie
Nancy, France, 54042
Germany
Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin
Berlin, Germany, 13353
Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin
Giessen, Germany, 35392
Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin
Potsdam, Germany, 14467
Netherlands
Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde
Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Jean Michel Hascoet, Prof. Maternité régionale de Nancy

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01880970     History of Changes
Other Study ID Numbers: 07.20.INF
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: July 2014
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Fever
Body Temperature Changes
Signs and Symptoms