In this study, the effect that a baby formula containing prebiotics and probiotics has on the gut flora of healthy newborns and infants, is examined. size and weight gain, general health status, breastmilk sample analysis (optional), allergen-sensitization (optional)
Conditions
Interventions
Group 1: The study participants receive infant formula (pre, stage 1 and 2) in case they need to supplement (not enough breastmilk available) or choose not to breast-feed or after weaning the child.
Sponsors
Technische Universität München, ZIEL - Institute for Food and Health, Lehrstuhl für Ernährung und Immunologie
Eligibility
Sex/Gender
All
Age
0 Days to 1 Weeks
Inclusion criteria
Inclusion criteria: Newborns. Pregnant women in the third trimester (starting at week 29) are recruited for this study. The pregnant mother must be at least 18 years old. Both parents or the legal guardian have to sign the consent form for the baby to be included in the study.
Exclusion criteria
Exclusion criteria: - Body-Mass-Index of the mother pre-pregnancy: below 18,5 or above 30 - preterm delivery (birth of the child before completion of the 37th week) - antibiotics treatment of the mother in the last 2 months of the pregnancy - physical or psychological illness of the mother which prevents or hinders the participation in the study (preparing the formula, feeding and taking samples) - infants with birth defects which affect the intake of food or digestion - infants that stayed at the intensive care unit in the hospital for more than three days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial diversity (richness), analyzed via 16S rRNA sequencing. Fecal samples from the participants are collected five times during the first year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolite analysis via mass spectrometry analysis to determine metabolic changes | — |
Countries
Germany
Contacts
Public ContactNina Heppner
Technische Universität München, Lehrstuhl für Ernährung und Immunologie
Outcome results
None listed