Healthy term born infants, born to healthy pregnant women
Conditions
Interventions
Mothers who gave birth by CS will be randomised to one of the three intervention groups:
1. Investigational group I receiving formula with a mixture of prebiotics during the first 16 weeks of life
2. Investigational group II receiving formula with a mixture of synbiotics during the first 16 weeks of life
3. Control group receiving comparable infant standard formula with no supplementation of pre- or synbiotics during the first 16 weeks of life.
In parallel, one group of infants who are delivered vagi
Sponsors
Danone Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy term born infants, born to healthy pregnant women; 2. Parents are willing and able to comply with the protocol; 3. Mother is willing to refrain from participation in any other intervention study; 4. Mother is willing to refrain 2 weeks prior to expected date of delivery from use of probiotic supplements or food products with added probiotics and use of dietary supplements containing prebiotics or dietary fiber; 5. Mothers who are breastfeeding are willing to refrain from the above mentioned supplements, antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs) while breastfeeding, if possible; 6. Written informed consent from parents.
Exclusion criteria
Exclusion criteria: For the mothers: 1. Fever ≥ 38.5° during the last week before birth; 2. Preterm birth before 37th week of gestation; 3. Occurrence of Eclampsia and Preeclampsia during the pregnancy; 4. Antenatal steroid treatment, except antenatal steroid treatment to prevent premature delivery; 5. Use of non-steroidal anti-inflammatory drugs (NSAIDs); 6. Antenatal antibiotics treatment (2 weeks before birth, except for prophylactic use during Caesarean delivery); 7. Diabetes mellitus requiring insulin treatment during pregnancy; 8. Uncontrollable Hyperthyroidism during pregnancy; 9. Severe abnormal Cardiotocogram for more than 2 hours at day of delivery leading to emergency CS; 10. Probiotic and prebiotic supplementation during the last 2 weeks of gestation; 11. Mothers treated for subfertility/infertility using assisted reproductive technologies; 12. Investigator’s uncertainty about the willingness or ability of the subject to comply with the protocol requirements. For the neonates: 1. Any known congenital disease which could interfere with the study conduct and assessments; 2. Any serious disease that could interfere with the study conduct and assessments; 3. Abnormal birth weight (normal ranges: 2.25 – 4 kg); 4. Apgar score <7 after 5 min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of the two test products compared to the effect of the control product in infants delivered by Caesarean section on the total bifidobacteria count of the gut microbiota. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of the two test products compared to the effect of the control product in infants delivered by Caesarean section on the bifidobacteria distribution, the composition of other members of the gut microbiota and metabolic activity. For the reference group bifidobacteria distribution, the composition of other members of the gut microbiota and metabolic activity will be measured in. | — |
Contacts
Public ContactFiona Wong
11 Biopolis Way Helios #09-01/02
Outcome results
None listed