Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-30 @ 9:13 AM
Study NCT ID:
NCT03062995
Status:
WITHDRAWN
Last Update Posted:
2021-12-23
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Nutricia Research
Organization:
Study Overview
Official Title:
A Randomised, Double-blind, Controlled, Parallel-group, Multi-country 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
Status:
WITHDRAWN
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study design not adequate anymore
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAESTRO
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: