Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infection
- Sponsor
- Beneo-Institute
- Enrollment
- 160
- Locations
- 8
- Primary Endpoint
- Incidence of infections during first year of life
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Incidence of infections during first year of life
Time Frame: until infant reaches age of 1 year
measured through presence of fever, and number and duration of infectious episodes
Secondary Outcomes
- Stool frequency(until infant reaches age of 1 year)
- Body height(until infant reaches age of 1 year)
- Crying episodes(until infant reaches age of 1 year)
- Stool consistency(until infant reaches age of 1 year)
- Sleeping habits(until infant reaches age of 1 year)
- Effect on fecal microbiota composition(until infant reaches age of 1 year)
- Digestive tolerance(until infant reaches age of 1 year)
- Growth(until infant reaches age of 1 year)
- Body weight(until infant reaches age of 1 year)
- Head circumference(until infant reaches age of 1 year)
- Effect on development of allergy(until infant reaches age of 1 year)
- Effect on immunology markers in feces(until infant reaches age of 1 year)