The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.
The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
160
standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans
standard infant formula not supplemented with prebiotic inulin-type fructans
ZNA Koningin Paola Kinderziekenhuis
Antwerp, Belgium
Universitair Ziekenhuis
Brussels, Belgium
CAP Llefià
Barcelona, Spain
Hospital de Nens
Barcelona, Spain
Incidence of infections during first year of life
measured through presence of fever, and number and duration of infectious episodes
Time frame: until infant reaches age of 1 year
Stool frequency
Number of depositions per day assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
Time frame: until infant reaches age of 1 year
Stool consistency
Assessed via 1-3 scale with pictograms (1=hard, 2=soft/formed, 3=liquid/semi-liquid), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
Time frame: until infant reaches age of 1 year
Digestive tolerance
Number of vomiting and regurgitation episodes per day and presence of excessive flatulence and infantile colic, assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
Time frame: until infant reaches age of 1 year
Growth
Calculation of z-scores of weight-for-age and length-for-age according to the World Health Organisation (WHO) standards using WHO software (WHO Antro software).
Time frame: until infant reaches age of 1 year
Body weight
Assessment of weight (kg) of the nude infant via calibrated electronic scales at all study visits.
Time frame: until infant reaches age of 1 year
Body height
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Hospital Sant Joan de Deu
Barcelona, Spain
University Hospital Vall d'Hebron
Barcelona, Spain
Hospital San Cecilio
Granada, Spain
Equipo Pediátrico San Francisco
Madrid, Spain
Assessment of height (cm) in supine position by using a standard measuring board at all study visits.
Time frame: until infant reaches age of 1 year
Head circumference
Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits.
Time frame: until infant reaches age of 1 year
Sleeping habits
Assessment of total hours slept and total hours of nocturnal sleeping per day (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).
Time frame: until infant reaches age of 1 year
Crying episodes
Assessment of crying episodes (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).
Time frame: until infant reaches age of 1 year
Effect on fecal microbiota composition
Quantification of dominant bacterial groups
Time frame: until infant reaches age of 1 year
Effect on development of allergy
Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema
Time frame: until infant reaches age of 1 year
Effect on immunology markers in feces
secretory immunoglobulin A, calprotectin level
Time frame: until infant reaches age of 1 year