Clinical trial NCT04441359: Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula
Official title: Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Microbial Colonization
Healthy
Lead sponsor: Beneo-Institute
Sponsor class: INDUSTRY
Collaborators: name: Laboratorios Ordesa
name: European Union
First posted: 2020-06-22
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

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)

Primary outcomes:
measure: Incidence of infections during first year of life
timeFrame: until infant reaches age of 1 year
Secondary outcomes:
measure: Stool frequency
timeFrame: until infant reaches age of 1 year
measure: Stool consistency
timeFrame: until infant reaches age of 1 year
measure: Digestive tolerance
timeFrame: until infant reaches age of 1 year
measure: Growth
timeFrame: until infant reaches age of 1 year
measure: Body weight
timeFrame: until infant reaches age of 1 year
measure: Body height
timeFrame: until infant reaches age of 1 year
measure: Head circumference
timeFrame: until infant reaches age of 1 year
measure: Sleeping habits
timeFrame: until infant reaches age of 1 year
measure: Crying episodes
timeFrame: until infant reaches age of 1 year
measure: Effect on fecal microbiota composition
timeFrame: until infant reaches age of 1 year
measure: Effect on development of allergy
timeFrame: until infant reaches age of 1 year
measure: Effect on immunology markers in feces
timeFrame: until infant reaches age of 1 year
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: ZNA Koningin Paola Kinderziekenhuis
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis
city: Barcelona
country: Spain
facility: CAP Llefià
city: Barcelona
country: Spain
facility: Hospital de Nens
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Madrid
country: Spain
facility: Equipo Pediátrico San Francisco
Study officials:
References:
citation: Rodriguez-Palmero, M.; Campoy, C.; Urraca, O.; Alonso, J.; Maldonado, J.; Varea, V.; Palencia, J.; Veereman-Wauters, G.; Neumer, F.; Rivero, M.; Vandenplas, Y. Effects of long-term supplementation with a mixture of short and long chain inulin-type oligosaccharides (2013), Annals of Nutrition and Metabolism, suppl. 1, (63), 1-1960.