Study to investigate the nutritional efficacy and tolerance of an infant formula with an added synbiotic mixture in infants
| ISRCTN | ISRCTN23993517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23993517 |
| Secondary identifying numbers | 100.008 |
- Submission date
- 12/11/2012
- Registration date
- 19/12/2012
- Last edited
- 19/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Danone Research B.V.
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands
Study information
| Study design | Randomised controlled double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Study acronym | ATOS |
| Study objectives | The effect of the test formula is equal to the effect of the control formula. |
| Ethics approval(s) | Ethik-Kommission der Medizinishcen Fakultät der Ruhr-Universität Bochurm, 29 September 2004 ref: 2406 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Weight gain over 13 weeks |
| Secondary outcome measures | 1. Growth 2. Gastro-intestinal tolerance 3. Atopic symptoms 4. Gut microbiota composition |
| Overall study start date | 01/04/2005 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 228 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- Germany
- Netherlands
Study participating centre
6704 PH
Netherlands
Sponsor information
Industry
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands
| Website | http://www.danone.com/ |
|---|---|
"ROR" |
https://ror.org/01c5aqt35 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
