Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02425423

Acronym

SONAR

Enrollment

100

Registered

2015-04-24

Start date

2013-06-30

Completion date

2014-06-30

Last updated

2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Brief summary

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

Interventions

DIETARY_SUPPLEMENTNew thickened formula

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 5 Months

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Number of episodes of regurgitation per day	14 days

Secondary

Measure	Time frame	Description
Regurgitation score	14 days	—
Digestive tolerance (stools' number and consistency)	14 days	Digestive tolerance of the formula assessed through stools' number and consistency
Growth parameters (Weight, height and head circumference)	3 months	Weight, height and head circumference

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026