SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01) (SWAN)

November 13, 2017 updated by: United Pharmaceuticals

Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Universitair Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants :

    • Aged ≤ 5 months old
    • fully formula fed
    • with at least 5 episodes of regurgitation per day, for at least a week

Exclusion Criteria:

  • Breast fed infants
  • Infants presenting symptoms of a complicated gastroesophageal reflux
  • Infants presenting intestinal disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thickened infant formula
Dietary supplement: Thickened infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of episodes of regurgitation per day
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Regurgitation score assessed through Vandenplas score
Time Frame: 14 and 90 days
14 and 90 days
Stools frequency over 72h
Time Frame: 14 and 90 days
14 and 90 days
Stools consistency assessed through Bristol Stool form Scale
Time Frame: 14 and 90 days
14 and 90 days
Weight expressed in z scores according to the WHO Child Growth Standards
Time Frame: 90 days
90 days
Height expressed in z scores according to the WHO Child Growth Standards
Time Frame: 90 days
90 days
BMI expressed in z scores according to the WHO Child Growth Standards
Time Frame: 90 days
90 days
Head circumference expressed in z scores according to the WHO Child Growth Standards
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Pharmaceuticals

Investigators

  • Principal Investigator: Yvan Vandenplas, MD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 21, 2017

Study Completion (Actual)

April 12, 2017

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01-SWAN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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