Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula

NCT ID: NCT02425423

Last Updated: 2015-04-24

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

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.

Detailed Description

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Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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New thickened infant formula

Group Type EXPERIMENTAL

New thickened formula

Intervention Type DIETARY_SUPPLEMENT

Interventions

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New thickened formula

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Infants :

* Aged ≤ 5 months old
* fully formula fed
* with at least 5 episodes of regurgitation per day

Exclusion Criteria

* Breast fed infants
* Infants presenting symptoms of a complicated gastroesophageal reflux
* Infants presenting intestinal disorders
Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yvan Vandenplas, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Pediatricians

Belgium, , Belgium

Site Status

Universitair Ziekenhuis

Brussels, , Belgium

Site Status

Pediatricians

France, , France

Site Status

Countries

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Belgium France

Other Identifiers

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2013-01-SONAR

Identifier Type: -

Identifier Source: org_study_id

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