Healthy term born neonates born to healthy pregnant mothers either by caesarean section or vaginally
Conditions
Interventions
Duration of intervention: 16 weeks
1. Intervention group:
The participants will receive additional to regular feeding a supplement containing Pre- and Probiotics.
2. Control group:
The control p
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy term born neonates born to healthy pregnant mothers; 2. Mother is willing and able to comply with the protocol, including refrain from 2 weeks prior to study start (expected date of delivery) and for the duration of the study from the: A. Use of probiotic supplements and food containing supplemented probiotics; B. Use of prebiotic or fibre supplements; C. Participation in any other intervention study. 3. Parents have given written informed consent.
Exclusion criteria
Exclusion criteria: For the mothers: 1. Use of antibiotics (except antibiotic treatment related to CS) from 2 weeks prior to delivery for duration of the study; 2. Use of non-steriodal anti-inflammatory drugs (NSAIDs) from 2 weeks prior to delivery for duration of the study; 3. Fever 38.5 degrees or more during the last week before birth; 4. Blood pressure systolic ¡Ý 160 mm Hg and diastolic ¡Ý 100 mm Hg; 5. Occurrence of Eclampsia and Preeclampsia during the pregnancy; 6. Antenatal steroid treatment; 7. Antenatal antibiotics treatment (2 weeks before birth); 8. Diabetes mellitus requiring insulin treatment; 9. Hyperthyroidism during pregnancy; 10. Pathologic birth presentation; 11. Abnormal Cardiotocogram for more than 2 hours at day of delivery; 12. Preterm birth before 37th week of gestation; 13. Probiotic and prebiotic supplementation during the last 2 weeks of gestation; 14. Mothers treated for infertility; 15. Placenta implementation; 16. Any known atopic diseases or food allergies in family history; 17. 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: girls 2.7 ¨C 5 kg; boys 2.9 ¨C 5.2 kg); 4. Apgar score < 7 after 10 min; 5. Any medical condition requiring antibiotic therapy after birth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exploratory Parameters: 1. Composition and metabolic activity of the gut microbiota, assessed by Fluorescent in situ hybridization (FISH) and real time PCR (RT-PCR); 2. Gastrointestinal tolerance; 3. (Serious) adverse events; 4. Anthropometry: anthropometric data will be measured/recorded according to the visits. | — |
Contacts
Public ContactKathrin Friedrichs
Bahnstrasse 14-30
Outcome results
None listed