Effect of a new synbiotic mixture of short chain galacto-oligosaccharides, long chain fructo-oligosaccharides and Bifidobacterium strain on the gut microbiota of caesarean delivered infants.
Suspended
- Conditions
- Healthy term born neonates born to healthy pregnant mothers either by caesarean section or vaginally
- Registration Number
- NL-OMON25311
- Lead Sponsor
- Danone Research – Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 180
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:
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Exploratory Parameters:<br /><br>1. Composition and metabolic activity of the gut microbiota, assessed by Fluorescent in situ hybridization (FISH) and real time PCR (RT-PCR);<br /><br>2. Gastrointestinal tolerance;<br /><br>3. (Serious) adverse events;<br /><br>4. Anthropometry: anthropometric data will be measured/recorded according to the visits.<br>
- Secondary Outcome Measures
Name Time Method