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Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.

P

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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