Study to investigate the nutritional efficacy and tolerance of an infant formula with an added synbiotic mixture in infants

Completed

• Conditions: Healthy infants; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN23993517
• Lead Sponsor: Danone Research B.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight gain over 13 weeks

Secondary Outcome Measures

Name	Time	Method
1. Growth<br>2. Gastro-intestinal tolerance<br>3. Atopic symptoms<br>4. Gut microbiota composition