NCT02710955

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 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

First Submitted

Initial submission to the registry

March 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
Last Updated

November 14, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

March 8, 2016

Last Update Submit

November 13, 2017

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Number of episodes of regurgitation per day

    14 days

Secondary Outcomes (7)

  • Regurgitation score assessed through Vandenplas score

    14 and 90 days

  • Stools frequency over 72h

    14 and 90 days

  • Stools consistency assessed through Bristol Stool form Scale

    14 and 90 days

  • Weight expressed in z scores according to the WHO Child Growth Standards

    90 days

  • Height expressed in z scores according to the WHO Child Growth Standards

    90 days

  • +2 more secondary outcomes

Study Arms (1)

Thickened infant formula

EXPERIMENTAL
Dietary Supplement: Thickened infant formula

Interventions

Thickened infant formulaDIETARY_SUPPLEMENT
Thickened infant formula

Eligibility Criteria

Age1 Week - 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, for at least a week

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 (1)

Universitair Ziekenhuis

Brussels, Belgium

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
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 17, 2016

Study Start

April 1, 2016

Primary Completion

January 21, 2017

Study Completion

April 12, 2017

Last Updated

November 14, 2017

Record last verified: 2017-05

Locations

BE(1)