This study does not focus on health problems, but on the effect of commercially available infant formula on the colonization process of healthy newborns.
Conditions
Interventions
Group 1: Infant formula with probiotics: Mothers who decide to breast-feed their offsprings will get probiotic follow-up formula after weaning (from approx. 6th month on) until the 12th month of infan
Sponsors
Töpfer Babynahrungs GmbH
Eligibility
Sex/Gender
All
Age
0 Days to 0 Days
Inclusion criteria
Inclusion criteria: Newborns from day 0 on. Recruitment therefore starts before delivery, addressing women in approximately 30th week of pregnancy. Their minimum age must be 18 years. Informed consent must be signed by both parents.
Exclusion criteria
Exclusion criteria: Preterm delivery, high-risk pregnancy, caesarian section, chronis diseases of the mother (e.g. diabetes mellitus I, II, inflammatory bowel disease,...), psychic or psychosomatic diseases of the mother, body mass index (BMI) (of the mother before pregnancy) 30, therapy in the last 2 months of pregnancy (e.g. with antibiotics, steroids,...)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial Diversity. Analysis from fecal samples, taken once per month for 12 months. Bacterial diversity will be determined via 16S rRNA pyrosequencing | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional Analysis. Analysis on a functional level will be achieved by metagenome and metabolome analysis. Metagenomics via sequencing serves to analyse the whole genome (DNA) for functional changes between different samples. Metabolome analysss via mass spectrometry allows to determine changes in metabolite levels (changes in metabolism). | — |
Countries
Germany
Contacts
Public ContactMonika Bazanella
Zentralinstitut für Ernährungs- und Lebensmittelforschung, Lehrstuhl für Biofunktionalität, Technische Universität München
Outcome results
None listed