Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.

March 18, 2019 updated by: Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
Recurrent regurgitation stress the infants and their parents and often results in an inappropirate use of PPI prescription in infancy. The aim of this study is to evaluate the efficacy of Mg alginate in infants with symptoms of gastroesophageal reflux.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 3

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

  • Italy
      • Bari, Italy, 70124
        • Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital

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 year to 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised: I-GERQ-R > 16)
  • informed consent signed

Exclusion Criteria:

  • congenital or chronic diseases
  • use of anti acid drugs

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: thickened formula
Dietary supplement: Mg alginate
Mg alginate after feedings
Experimental: Mg alginate
Dietary supplement: Mg alginate
Mg alginate after feedings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Gastro-Esophageal Reflux Questionnaire Revised
Time Frame: through study completion, an average of 1 month
12-item validated questionnaire called Infant Gastro-Esophageal Reflux Questionnaire Revised (I-GERQ-R) which include different questions about regurgitation, crying, feeding and respiratory problems
through study completion, an average of 1 month

Collaborators and Investigators

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

Sponsor

Policlinico Hospital

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 (Actual)

June 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 17, 2018

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALGNEO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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