Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/11/2012
Date assigned
19/12/2012
Last edited
19/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Ms Mieke Roelofs

ORCID ID

Contact details

Danone Research B.V.
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands

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, 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

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

http://www.danone.com/

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

Publication citations

Additional files

Editorial Notes