Intestinal microbiota Digestive System Intestinal microbiota
Conditions
Interventions
The subjects will be selected by SGS LIFE SCIENCE SERVICES, under the supervision of the principal investigator. The principal investigator and his/her study team will cooperate with gynaecologists an
Sponsors
Yakult Honsha European Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy pregnant female at 24 weeks of pregnancy 2. Normal course of pregnancy 3. Written Informed Consent dated and signed by the mother 4. Good physical and mental health status as determined by medical history and general clinical examination according to the investigators judgment 5. Considered as reliable and capable of adhering to the protocol, according to the investigator
Exclusion criteria
Exclusion criteria: 1. Birth in water 2. Participation in another clinical trial during the study or within 60 days before delivery 3. Alcohol consumption of more than 7 units per week (1 unit being a glass of beer, wine or a measure of spirits) 4. Reported current usage of illegal drugs After delivery: 1. Prematurely-born neonate (before 37 weeks of pregnancy) 2. In case a subject has decided to resign from further participation in the study 3. In case a subject suffers from a bacterial/viral infection within 2 weeks before delivery 4. In case a subject delivers a baby with major congenial malformation(s) 5. In case the subject and/or the baby use immunomodulatory drugs between 4 weeks prior to delivery and the end of the study (6 months after delivery) 6. In case the subject and/or the baby use antibiotics between 2 weeks prior to delivery and 2 weeks after the delivery, for any reason except for a prophylactic use (e.g. caesarean section)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Faecal microbiota composition of the mothers and neonates. The faecal microbiota composition of the mother will be measured 2 times (with one week interval) between 1 and 2 months before the delivery. The faecal microbiota composition of the neonates will be measured in the first faecal sample of the neonates and two days later, and at one week, one month, 3 months and 6 months of life. If the baby starts with weaning food during the study period, 1 faecal sample needs to be collected 1 week after start of weaning. 2. Faecal short chain fatty acids (SCFA) and faecal lactate, measured at the same timepoints as that of the faecal microbiota 3. Microbiota composition of the breast milk. The microbiota composition of the breast milk will be measured before delivery when possible, and after delivery (colostrums) if possible, at 1 week and 1 month after delivery. 4. Oligosaccharides quantification in breast milk, measured at the same timepoints as that of the breast milk microbiota 5. Lipid quantification in breast milk, measured at the same timepoints as that of the breast milk microbiota 6. Protein quantification in breast milk, measured at the same timepoints as that of the breast milk microbiota | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Belgium
Outcome results
None listed