NCT03881722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

2.5 years

First QC Date

February 17, 2018

Last Update Submit

March 18, 2019

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • 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

    through study completion, an average of 1 month

Study Arms (2)

thickened formula

ACTIVE COMPARATOR
Dietary Supplement: Mg alginate

Mg alginate

EXPERIMENTAL
Dietary Supplement: Mg alginate

Interventions

Mg alginateDIETARY_SUPPLEMENT

Mg alginate after feedings

Mg alginatethickened formula

Eligibility Criteria

Age3 Weeks - 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised: I-GERQ-R \> 16)
  • informed consent signed

You may not qualify if:

  • congenital or chronic diseases
  • use of anti acid drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized controlled cross-over trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 17, 2018

First Posted

March 19, 2019

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)