Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03881722

Enrollment

Registered

2019-03-19

Start date

2016-06-30

Completion date

2018-12-31

Last updated

2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Esophageal Reflux

Brief 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.

Interventions

DIETARY_SUPPLEMENTMg alginate

Mg alginate after feedings

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized controlled cross-over trial

Eligibility

Sex/Gender

ALL

Age

3 Weeks to 1 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Infant Gastro-Esophageal Reflux Questionnaire Revised	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026