Development of Fecal Microbiota in Infants Fed With Formula With or Without Probiotics. Randomized, double-blind, controlled pilot study

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2012
INTERVENTION: Intervention 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 infant life. Insufficient breast milk supply to the newborn during the first months will be compensated by probiotic starter formula. Women who do not breast feed get probiotic starter formula, which will be given right after birth, and after 6 months probiotic follow‐up formula until the 12th month of infant life. How often and how much milk will be given to the offsprings will exclusively be decided by the parents. Intervention 2: Infant formula without probiotics: Mothers who decide to breast‐feed their offsprings will get non‐probiotic follow‐up formula after weaning (from approx. 6th month on) until the 12th month of infant life. Insufficient breast milk supply to the newborn during the first months will be compensated by non‐probiotic starter formula. Women who do not breast‐feed get non‐probiotic starter formula, which will be given right after birth, and after 6 months non‐probiotic follow‐up formula until the 12th month of the infant's life. How often and how much milk will be given to the offsprings will exclusively be decided by the parents. CONDITION: This study does not focus on health problems, but on the effect of commercially available infant formula on the colonization process of healthy newborns. PRIMARY OUTCOME: Bacterial Diversity. Analysis from fecal samples, taken once per month for 12 months. Bacterial diversity will be determined via 16S rRNA pyrosequencing SECONDARY OUTCOME: 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). 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.
Epistemonikos ID: 81e71594c81ef6eb3215de9e7e3e6cfa4d44ff0b
First added on: Aug 22, 2024