SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)

Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02710955

Acronym

SWAN

Enrollment

100

Registered

2016-03-17

Start date

2016-04-01

Completion date

2017-04-12

Last updated

2017-11-14

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_SUPPLEMENTThickened infant formula

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Weeks to 5 Months

Healthy volunteers

Inclusion criteria

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

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
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
BMI expressed in z scores according to the WHO Child Growth Standards	90 days
Head circumference expressed in z scores according to the WHO Child Growth Standards	90 days

Countries

Belgium

Outcome results

None listed

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