Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-01

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Infection Microbial Colonization Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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supplemented formula

Standard formula supplemented with prebiotic inulin-type fructans

Group Type EXPERIMENTAL

Supplemented formula

Intervention Type OTHER

standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans

standard formula

Standard Formula not supplemented with prebiotic inulin-type fructans

Group Type PLACEBO_COMPARATOR

Standard formula

* 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)

Minimum Eligible Age

1 Day

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes