Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441359
• Other study ID #: Study protocol June 2008 final
• Status: Completed
• Phase: N/A
• Start date: June 1, 2008
• Est. completion date: October 31, 2010

Study information

• Verified date: June 2020
• Source: Beneo-Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 31, 2010
• Est. primary completion date: October 31, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Healthy
• Infection
• Microbial Colonization

Intervention

Other:
• Supplemented formula
standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans
• Standard formula
standard infant formula not supplemented with prebiotic inulin-type fructans

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Beneo-Institute	European Union, Laboratorios Ordesa

Countries where clinical trial is conducted

Belgium,  Spain, 

References & Publications (1)

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 oligosa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Head circumference	Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits.	until infant reaches age of 1 year
Secondary	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
Secondary	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
Secondary	Effect on fecal microbiota composition	Quantification of dominant bacterial groups	until infant reaches age of 1 year
Secondary	Effect on development of allergy	Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema	until infant reaches age of 1 year
Secondary	Effect on immunology markers in feces	secretory immunoglobulin A, calprotectin level	until infant reaches age of 1 year