Infection, Microbial Colonization, Healthy
Conditions
Brief summary
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.
Detailed description
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).
Interventions
OTHERSupplemented formula
standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans
OTHERStandard formula
standard infant formula not supplemented with prebiotic inulin-type fructans
Sponsors
Laboratorios Ordesa
European Union
Beneo-Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 4 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97) * Healthy babies aged between 0 - 4 months of age * Babies exclusively fed with an infant formula on enrolment into the study
Exclusion criteria
* The presence of an infection at the moment of the recruitment or 1 week before recruitment * The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.) * Any other diseases related to the immune system (primary immunodeficiency) * Parents not able to comply with the study follow up (according to physician criteria)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infections during first year of life | until infant reaches age of 1 year | measured through presence of fever, and number and duration of infectious episodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool consistency | until infant reaches age of 1 year | 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) |
| Digestive tolerance | until infant reaches age of 1 year | 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) |
| Growth | until infant reaches age of 1 year | 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). |
| Body weight | until infant reaches age of 1 year | Assessment of weight (kg) of the nude infant via calibrated electronic scales at all study visits. |
| Body height | until infant reaches age of 1 year | Assessment of height (cm) in supine position by using a standard measuring board at all study visits. |
| Stool frequency | until infant reaches age of 1 year | Number of depositions per day assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period) |
| Sleeping habits | until infant reaches age of 1 year | 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). |
| Crying episodes | until infant reaches age of 1 year | Assessment of crying episodes (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period). |
| Effect on fecal microbiota composition | until infant reaches age of 1 year | Quantification of dominant bacterial groups |
| Effect on development of allergy | until infant reaches age of 1 year | Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema |
| Effect on immunology markers in feces | until infant reaches age of 1 year | secretory immunoglobulin A, calprotectin level |
| Head circumference | until infant reaches age of 1 year | Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits. |
Countries
Belgium, Spain
Outcome results
None listed