NCT02806453

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

June 16, 2016

Last Update Submit

June 19, 2016

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Evaluation of symptom scores

    Infant Gastroesophageal Reflux Questionnaire Revised

    From day 0 to day 35

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A: Mg alginate/thickened formula

Dietary Supplement: thickened formulaDietary Supplement: Mg alginateBehavioral: reassurance with lifestyle changes

Group B

ACTIVE COMPARATOR

Group B: thickened formula/Mg alginate

Dietary Supplement: thickened formulaDietary Supplement: Mg alginateBehavioral: reassurance with lifestyle changes

Interventions

thickened formulaDIETARY_SUPPLEMENT
Group AGroup B
Mg alginateDIETARY_SUPPLEMENT
Group AGroup B
reassurance with lifestyle changesBEHAVIORAL
Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • full-term ages 3 to 12 months, affected by symptoms suggestive of GER.
  • infant regurgitation defined according to the Rome IV criteria
  • informed consent

You may not qualify if:

  • 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

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 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 20, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

June 21, 2016

Record last verified: 2016-06

Locations

IT(1)