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Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881722
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Maria Elisabetta Baldassarre, Policlinico Hospital

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.

Condition or disease Intervention/treatment Phase
Gastro Esophageal Reflux Dietary Supplement: Mg alginate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized controlled cross-over trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: thickened formula Dietary Supplement: Mg alginate
Mg alginate after feedings

Experimental: Mg alginate Dietary Supplement: Mg alginate
Mg alginate after feedings




Primary Outcome Measures :
  1. Infant Gastro-Esophageal Reflux Questionnaire Revised [ Time Frame: through study completion, an average of 1 month ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881722


Locations
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Italy
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, Italy, 70124
Sponsors and Collaborators
Policlinico Hospital
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Responsible Party: Prof. Maria Elisabetta Baldassarre, Researcher, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT03881722    
Other Study ID Numbers: ALGNEO1
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases