Plain English Summary
Background and study aims:
This study aimed to demonstrate that the new infant formula does not affect growth and infants were tolerant to the new formula.
Who can participate?
Healthy term babies, aged under 35 days.
What does the study involve?
Healthy term infants were randomly allocated to receive either the new infant formula or the standard formula for 13 weeks. During this period participants visited the hospital every 4 weeks to measure growth (e.g. weight, length, head circumference) and other factors (e.g. digestive symptoms).
What are the possible benefits and risks of participating?
All participants will receive one of the study formulas during the course of the study. Based on current knowledge there are no known risks anticipated with participating in the study.
Where is the study run from?
Hospitals in Germany.
When is the study starting and how long is it expected to run for?
Recruitment for the study started in April 2005 and ended in May 2007.
Who is funding the study?
Danone Research Centre for Specialised Nutrition, The Netherlands
Who is the main contact?
Dr Mieke Roelofs
mieke.roelofs@danone.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
100.008
Study information
Scientific title
Study to investigate the nutritional efficacy and Acceptance/Tolerance characteristics Of an extensively hydrolyzed whey protein formula with added Synbiotics in infants (ATOS)
Acronym
ATOS
Study hypothesis
The effect of the test formula is equal to the effect of the control formula.
Ethics approval
Ethik-Kommission der Medizinishcen Fakultät der Ruhr-Universität Bochurm, 29 September 2004 ref: 2406
Study design
Randomised controlled double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Healthy infants
Intervention
Duration of intervention: 13 weeks.
Intervention group: receiving an infant formula with an added symbiotic mixture for 13 weeks.
Control group: receiving an infant formula without an added symbiotic mixture for 13 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Weight gain over 13 weeks
Secondary outcome measures
1. Growth
2. Gastro-intestinal tolerance
3. Atopic symptoms
4. Gut microbiota composition
Overall trial start date
01/04/2005
Overall trial end date
01/05/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
228
Participant 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, downs 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
Recruitment start date
01/04/2005
Recruitment end date
01/05/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Danone Research B.V.
Wageningen
6704 PH
Netherlands
Sponsor information
Organisation
Danone Research B.V. (The Netherlands)
Sponsor details
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Danone Research B.V. Centre for Specialised Nutrition (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary