Intestinal microbiota Digestive System Intestinal microbiota
Conditions
Interventions
Legally acceptable representative will fill out questionnaires regarding the subject’s disease
history and demographic as well as the Children’s Behaviour Questionnaire in order to exa
Sponsors
Yakult Honsha European Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects aged between 4 and 7, who participated as a neonate in Study Yak.1.C.A.
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical study during the study or within 30 days prior to entry in this study 2. A condition that, in the opinion of the Investigator, could compromise the well-being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study consists of “Screening day (S)”, “First faecal delivery day (F1: within 28 days after Screening day)” and “Second faecal delivery day (F2: within 7 to 9 days after F1)”. Subjects will not be allowed to drink fermented milk between F1 and F2 1. Subject’s disease history will be collected by questionnaire on F1, and additionally on F2 in order to follow the disease occurrence in the interval 2. Subject’s demographics will be collected by questionnaire on S, and additionally on F1 and F2 in order to follow the status of fermented milk and intestinal drugs (e.g. antibiotics) ingestion in the intervals 3. Children’s personality will be assessed based on Children’s Behavior Questionnaire collected on F1 4. Faecal microbial composition, diversity and the absolute number of specific bacteria will be analyzed by 16S rRNA metagenomics or quantitative polymerase chain reaction (PCR) targeting bacterial DNA extracted from the faeces collected on F1 and F2. Preserved bacterial DNA from Study YAK.1.C.A. will also be analyzed. 5. Persistence of bifidobacteria from early life will be evaluated by comparing the homogeneity of bifidobacterial strains isolated from faeces collected on F2 to those isolated in Study YAK.1. C.A. by using multilocus sequence typing (MLST) | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Belgium
Outcome results
None listed