Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Microbial Colonization; Infection
• Intervention / Treatment: Other: Supplemented formula; Other: Standard formula

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • ZNA Koningin Paola Kinderziekenhuis
  • Brussel, Belgium
    • Universitair Ziekenhuis
• Spain
  • Barcelona, Spain
    • Hospital Sant Joan De Deu
  • Barcelona, Spain
    • University Hospital Vall d'Hebron
  • Barcelona, Spain
    • Hospital de Nens
  • Barcelona, Spain
    • CAP Llefià
  • Granada, Spain
    • Hospital San Cecilio
  • Madrid, Spain
    • Equipo Pediátrico San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: supplemented formula; Standard formula supplemented with prebiotic inulin-type fructans	Other: Supplemented formula; standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans
Placebo Comparator: standard formula; Standard Formula not supplemented with prebiotic inulin-type fructans	Other: Standard formula; standard infant formula not supplemented with prebiotic inulin-type fructans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infections during first year of life	measured through presence of fever, and number and duration of infectious episodes	until infant reaches age of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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).	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.	until infant reaches age of 1 year
Body height	Assessment of height (cm) in supine position by using a standard measuring board at all study visits.	until infant reaches age of 1 year
Head circumference	Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits.	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).	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).	until infant reaches age of 1 year
Effect on fecal microbiota composition	Quantification of dominant bacterial groups	until infant reaches age of 1 year
Effect on development of allergy	Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema	until infant reaches age of 1 year
Effect on immunology markers in feces	secretory immunoglobulin A, calprotectin level	until infant reaches age of 1 year

Collaborators and Investigators

• Sponsor: Beneo-Institute
• Collaborators: European Union; Laboratorios Ordesa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2008
• Primary Completion (Actual): October 31, 2010
• Study Completion (Actual): October 31, 2010

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: Study protocol June 2008 final

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No