Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.

Gastroesophageal Reflux Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02806453
• Other study ID #: ALNEO1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 16, 2016
• Last updated: June 19, 2016
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee of Policlinico Hospital of Bari
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 99
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 1 Year

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Dietary Supplement:
• thickened formula

• Mg alginate

Behavioral:
• reassurance with lifestyle changes

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	Evaluation of symptom scores	Infant Gastroesophageal Reflux Questionnaire Revised	From day 0 to day 35	Yes