Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.

Policlinico Hospital

Status and phase: Unknown; Phase 4

Conditions: Gastroesophageal Reflux

Treatments: Dietary Supplement: Mg alginate; Behavioral: reassurance with lifestyle changes; Dietary Supplement: thickened formula

Study type: Interventional

Funder types: Other

Identifiers

NCT02806453

ALNEO1

Details and patient eligibility

About

A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised).

The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week.

Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.

Enrollment: 99 estimated patients

Sex: All

Ages: 3 months to 1 year old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• full-term ages 3 to 12 months, affected by symptoms suggestive of GER.
• infant regurgitation defined according to the Rome IV criteria
• informed consent

Exclusion criteria

• Evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (H2-receptor antagonists or proton pump inhibitors [PPIs]), thickened formula, or a history of prematurity or atopy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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99 participants in 2 patient groups

Group A

Active Comparator group

Description:

Group A: Mg alginate/thickened formula

Treatment:

Dietary Supplement: Mg alginate

Dietary Supplement: thickened formula

Behavioral: reassurance with lifestyle changes

Group B

Active Comparator group

Description:

Group B: thickened formula/Mg alginate

Treatment:

Dietary Supplement: Mg alginate

Dietary Supplement: thickened formula

Behavioral: reassurance with lifestyle changes