Prebiotic oligosaccharides and fermented formula study.
Completed
- Conditions
- Healthy term infants
- Registration Number
- NL-OMON20626
- Lead Sponsor
- Danone Research – Centre for Specialised Nutrition
- Brief Summary
The combination of scGOS/lcFOS and fermented infant formula softens stools of infants compared to unfermented infant formula without scGOS/lcFOSscGOS/lcFOS. Herrera AR, Ludwig T, Bouritius H, Rubio RP, Muñoz A, Agosti M, Lista G, Corvaglia LT, Navero JL. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):516-7
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Healthy and term infants (gestational age ≥ 37 and ≤ 42 weeks);
2. Infants who are exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ceased breastfeeding by time of inclusion), or;
Exclusion Criteria
1. Infants fed with infant formula containing probiotics or synbiotics prior to study entry;
2. Congenital condition and/or previous or current illness that could interfere with study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence, occurrence and severity of gastrointestinal symptoms.
- Secondary Outcome Measures
Name Time Method 1. To explore the effect on quality of life and on digestion-related parameters;<br /><br>2. To investigate adequate growth of the study product groups compared to WHO Child Growth Standards;<br /><br>3. To describe the data of the breastfed reference group.