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

Study to investigate the nutritional efficacy and Acceptance/Tolerance characteristics Of an extensively hydrolyzed whey protein formula with added Synbiotics in infants (ATOS)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23993517

Enrollment

228

Registered

2012-12-19

Start date

2005-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy infants Nutritional, Metabolic, Endocrine

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Secondary

Measure	Time frame
1. Growth 2. Gastro-intestinal tolerance 3. Atopic symptoms 4. Gut microbiota composition	—

Primary

Measure	Time frame
Weight gain over 13 weeks	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026