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NCT03881722 Clinical Trial

Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.

Gastro Esophageal Reflux Clinical Trial

Official title:
Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03881722
Other study ID # ALGNEO1
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2016
Est. completion date December 2018

Study information
Verified date March 2019
Source Policlinico Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 89
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 1 Year
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Mg alginate
Mg alginate after feedings

Locations
Country Name City State
Italy Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital Bari

Sponsors (1)
Lead Sponsor Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Infant Gastro-Esophageal Reflux Questionnaire Revised 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
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