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| [ Print-friendly version ] |
| Study to investigate the nutritional efficacy and tolerance of an infant formula with an added synbiotic mixture in infants |
| ISRCTN | ISRCTN23993517 |
| DOI | 10.1186/ISRCTN23993517 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Study to investigate the nutritional efficacy and tolerance of an infant formula with an added synbiotic mixture in infants |
| 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 |
| Serial number at source | 100.008 |
| Study hypothesis | The effect of the test formula is equal to the effect of the control formula. |
| Lay 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 |
| Ethics approval | Ethik-Kommission der Medizinishcen Fakultät der Ruhr-Universität Bochurm, 29 September 2004 ref: 2406 |
| Study design | Randomised controlled double-blind trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Healthy infants |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/04/2005 |
| Anticipated end date | 01/05/2007 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 228 |
| Interventions |
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. |
| Primary outcome measure(s) | Weight gain over 13 weeks |
| Secondary outcome measure(s) |
1. Growth
2. Gastro-intestinal tolerance 3. Atopic symptoms 4. Gut microbiota composition |
| Sources of funding | Danone Research B.V. – Centre for Specialised Nutrition (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Ms Mieke Roelofs |
| Address |
Danone Research B.V.
Centre for Specialised Nutrition Bosrandweg 20 |
| City/town | Wageningen |
| Zip/Postcode | 6704 PH |
| Country | Netherlands |
| Sponsor | Danone Research B.V. (The Netherlands) |
| Address |
Centre for Specialised Nutrition
Bosrandweg 20 |
| City/town | Wageningen |
| Zip/Postcode | 6704 PH |
| Country | Netherlands |
| Sponsor website: | http://www.danone.com/ |
| Date applied | 12/11/2012 |
| Last edited | 19/12/2012 |
| Date ISRCTN assigned | 19/12/2012 |
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