NCT02425423

Brief Summary

The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_3

Geographic Reach
2 countries

3 active sites

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, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

April 20, 2015

Last Update Submit

April 23, 2015

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Number of episodes of regurgitation per day

    14 days

Secondary Outcomes (5)

  • Regurgitation score

    14 days

  • Regurgitation score

    3 months

  • Digestive tolerance (stools' number and consistency)

    14 days

  • Digestive tolerance (stools' number and consistency)

    3 months

  • Growth parameters (Weight, height and head circumference)

    3 months

Study Arms (1)

New thickened infant formula

EXPERIMENTAL
Dietary Supplement: New thickened formula

Interventions

New thickened formulaDIETARY_SUPPLEMENT
New thickened infant formula

Eligibility Criteria

AgeUp to 5 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants :
  • Aged ≤ 5 months old
  • fully formula fed
  • with at least 5 episodes of regurgitation per day

You may not qualify if:

  • Breast fed infants
  • Infants presenting symptoms of a complicated gastroesophageal reflux
  • Infants presenting intestinal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pediatricians

Belgium, Belgium

Location

Universitair Ziekenhuis

Brussels, 1090, Belgium

Location

Pediatricians

France, France

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Yvan Vandenplas, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 24, 2015

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

FR(1)BE(2)