Infant Nutrition
Conditions
Keywords
human milk oligosaccharides, infant formula
Brief summary
The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.
Detailed description
The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well. As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.
Interventions
DIETARY_SUPPLEMENThuman milk oligosaccharides
mixture of five different human milk oligosaccharides
Sponsors
Analyze & Realize
Jennewein Biotechnologie GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
1 Days to 13 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton birth * Full-term infant (37 - 42 weeks of gestational age) * APGAR score of 9 or 10 * Birth weight 2500 - 4500 g
Exclusion criteria
* clinically significant condition/ disorder * Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula * readmission to hospital (except for hyperbilirubinemia) * allergy to cow's milk * participation in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessment of body weight (in grams) of term infants | 4 month | growth, assessed by body weight gain, of term infants from enrollment to 4 month of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assessment of body length (in centimeter) of term infants | 4 month | growth, assessed as body length, of term infants from enrollment to 4 month of life |
| assessment of head circumference (in centimeter) of term infants | 4 month | growth, assessed as head circumference, of term infants from enrollment to 4month of life |
Other
| Measure | Time frame | Description |
|---|---|---|
| product compliance | 4 month | intake of infant formula in ml |
| morbidity | 4 month | observation of illness |
| stool microbiota | 4 month | analysis of the fecal microbiota |
| influence of digestion | 4 month | digestive tolerance parameters ( e.g. rigurgitation, flatulence) will be assessed |
| digestive tolerance | 4 month | stool frequency and consistency |
| HMO composition in breast milk | 4 month | analysis of HMO composition in mothers breastmilk in the breast-fed arm |
| influence on behaviour | 4 month | behavior patterns (e.g.fussiness, cramps, awakings at night) will be assessed |
Countries
Germany, Italy, Spain
Outcome results
None listed