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Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.

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ClinicalTrials.gov Identifier: NCT02806453
Recruitment Status : Unknown
Verified June 2016 by Prof. Maria Elisabetta Baldassarre, Policlinico Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Maria Elisabetta Baldassarre, Policlinico Hospital

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.


Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Dietary Supplement: thickened formula Dietary Supplement: Mg alginate Behavioral: reassurance with lifestyle changes Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: Group A
Group A: Mg alginate/thickened formula
Dietary Supplement: thickened formula
Dietary Supplement: Mg alginate
Behavioral: reassurance with lifestyle changes
Active Comparator: Group B
Group B: thickened formula/Mg alginate
Dietary Supplement: thickened formula
Dietary Supplement: Mg alginate
Behavioral: reassurance with lifestyle changes



Primary Outcome Measures :
  1. Evaluation of symptom scores [ Time Frame: From day 0 to day 35 ]
    Infant Gastroesophageal Reflux Questionnaire Revised



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Ages Eligible for Study:   3 Months to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02806453


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, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT02806453     History of Changes
Other Study ID Numbers: ALNEO1
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases