Back to resultsEffect of Magnesium Alginate on Gastroesophageal Reflux in Infants.
Primary Purpose
Gastroesophageal Reflux
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
thickened formula
Mg alginate
reassurance with lifestyle changes
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux
Eligibility Criteria
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
Sites / Locations
- Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Group A: Mg alginate/thickened formula
Group B: thickened formula/Mg alginate
Outcomes
Primary Outcome Measures
Evaluation of symptom scores
Infant Gastroesophageal Reflux Questionnaire Revised
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02806453
Brief Title
Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A: Mg alginate/thickened formula
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B: thickened formula/Mg alginate
Intervention Type
Dietary Supplement
Intervention Name(s)
thickened formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Mg alginate
Intervention Type
Behavioral
Intervention Name(s)
reassurance with lifestyle changes
Primary Outcome Measure Information:
Title
Evaluation of symptom scores
Description
Infant Gastroesophageal Reflux Questionnaire Revised
Time Frame
From day 0 to day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
City
Bari
ZIP/Postal Code
70124
Country
Italy
12. IPD Sharing Statement
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Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.
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