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A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on the Development of Allergic Manifestations in Infants at High Risk of Developing Allergy

NCT03062995 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-12-23

No results posted yet for this study

Summary

With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority. It is generally acknowledged that breastfeeding is one of the main pillars in allergy prevention. Infant formulas based on hydrolysed proteins have been developed to be used by infants at increased risk of developing allergy in case a mother is unable or chooses not to breastfeed her infant. The effect of hydrolysed formula in allergy prevention has been examined in many studies, from which it can be concluded that currently there is not sufficient evidence to support hydrolysed protein over intact protein for allergy risk reduction. Moreover, several clinical trials support the suggestion of supplementation of pre and/or probiotics for the reduction of eczema development, recognized by international authorities. The present study (MAESTRO) investigates the preventive effect of a hypoallergenic concept combining several nutritional approaches related to preventive strategies: partially hydrolysed protein formula supplemented with prebiotics and probiotics. The aim of the present study is to investigate the efficacy, growth and safety of this concept compared to standard (intact protein) infant formula on the development of allergic manifestations up to the age of 12 months in infants at increased risk of developing allergy.

Conditions

  • Immunity

Interventions

OTHER

Infant Formula with added synbiotics

Intervention group: Infant Formula / Follow-On formula with partially hydrolysed cow's milk protein supplemented with prebiotics and probiotics.

OTHER

Standard Infant formula

Control group: Standard Infant Formula / Follow-On formula with intact cow's milk protein (only standard ingredients, without addition of pre- and probiotics).

Sponsors & Collaborators

  • Nutricia Research

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2023-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03062995 on ClinicalTrials.gov