Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

Not Applicable

Completed

• Conditions: Infection; Microbial Colonization; Healthy
• Interventions: Other: Standard formula; Other: Supplemented formula

• Registration Number: NCT04441359
• Lead Sponsor: Beneo-Institute

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).

Study Timeline

• Study Start: 2008-06-01
• Primary Completion: 2010-10-31
• Study Completion: 2010-10-31
• Status Verified: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-18
• Last Update Submitted: 2020-06-18
• Study First Posted: 2020-06-22
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard formula	Standard formula	Standard Formula not supplemented with prebiotic inulin-type fructans
supplemented formula	Supplemented formula	Standard formula supplemented with prebiotic inulin-type fructans

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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 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)
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
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.
Head circumference	until infant reaches age of 1 year	Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits.
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

Trial Locations

Locations (8)

Universitair Ziekenhuis; 🇧🇪 Brussel, Belgium

Hospital de Nens; 🇪🇸 Barcelona, Spain

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital San Cecilio; 🇪🇸 Granada, Spain

CAP Llefià; 🇪🇸 Barcelona, Spain

Hospital Sant Joan de Deu; 🇪🇸 Barcelona, Spain

ZNA Koningin Paola Kinderziekenhuis; 🇧🇪 Antwerp, Belgium

Equipo Pediátrico San Francisco; 🇪🇸 Madrid, Spain