Back to resultsEffect of Magnesium Alginate in Infants With Gastroesophageal Reflux.
Primary Purpose
Gastro Esophageal Reflux
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Mg alginate
Sponsored by
About this trial
This is an interventional treatment trial for Gastro Esophageal Reflux
Eligibility Criteria
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
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
Experimental
Arm Label
thickened formula
Mg alginate
Arm Description
Outcomes
Primary Outcome Measures
Infant Gastro-Esophageal Reflux Questionnaire Revised
12-item validated questionnaire called Infant Gastro-Esophageal Reflux Questionnaire Revised (I-GERQ-R) which include different questions about regurgitation, crying, feeding and respiratory problems
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03881722
Brief Title
Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.
Official Title
Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled cross-over trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
thickened formula
Arm Type
Active Comparator
Arm Title
Mg alginate
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Mg alginate
Intervention Description
Mg alginate after feedings
Primary Outcome Measure Information:
Title
Infant Gastro-Esophageal Reflux Questionnaire Revised
Description
12-item validated questionnaire called Infant Gastro-Esophageal Reflux Questionnaire Revised (I-GERQ-R) which include different questions about regurgitation, crying, feeding and respiratory problems
Time Frame
through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Plan to Share IPD
No
Learn more about this trial
Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.
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