Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.

Policlinico Hospital

Status and phase: Completed; Phase 3

Conditions: Gastro Esophageal Reflux

Treatments: Dietary Supplement: Mg alginate

Study type: Interventional

Funder types: Other

Identifiers

NCT03881722

ALGNEO1

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 3 weeks to 1 year old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

thickened formula

Active Comparator group

Treatment:

Dietary Supplement: Mg alginate

Mg alginate

Experimental group

Treatment:

Dietary Supplement: Mg alginate