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Clinical Trials/ISRCTN23993517
ISRCTN23993517
Completed
Not Applicable

Study to investigate the nutritional efficacy and Acceptance/Tolerance characteristics Of an extensively hydrolyzed whey protein formula with added Synbiotics in infants (ATOS)

Danone Research B.V. (The Netherlands)0 sites228 target enrollmentDecember 19, 2012
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ConditionsHealthy infantsNutritional, Metabolic, Endocrine

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy infants
Sponsor
Danone Research B.V. (The Netherlands)
Enrollment
228
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 19, 2012
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Danone Research B.V. (The Netherlands)

Eligibility Criteria

Inclusion Criteria

  • •1\. Healthy term infants (gestational age 37\- 42 weeks)
  • •2\. 0\-35 days of age
  • •3\. Normal birth weight dependent on gender, and week of delivery
  • •4\. Exclusively formula fed
  • •5\. Written informed consent by both parents

Exclusion Criteria

  • •1\. Infants with the following allergic symptoms:
  • •1\.1\. Atopic dermatitis prior to inclusion, according to the Hanifin criteria
  • •1\.2\. Wheezing
  • •2\. Previous use of antibiotics and therapeutic blood components by infant prior to inclusion
  • •3\. Previous use of antibiotics by the mother during breastfeeding prior to inclusion
  • •4\. Infants with congenital abnormality or chromosomal disorder disease (such as cystic fibrosis, tuberculosis, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, major congenital heart disease, down?s syndrome)
  • •5\. Parental history and pre\- or perinatal indications for inherited immunodeficiency syndromes.
  • •6\. Infants with congenital infections (Group B streptococcal disease, Hepatitis B, Toxoplasmose, Rubella, herpes, syphillis, Epstein Bar)
  • •7\. Infants requiring intubations or mechanical ventilation
  • •8\. Infants of mothers with a significant illness or disability

Outcomes

Primary Outcomes

Not specified

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