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

Gastroesophageal Reflux Clinical Trial

— SWAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710955
• Other study ID #: 2016-01-SWAN
• Status: Completed
• Phase: N/A
• First received: March 8, 2016
• Last updated: November 13, 2017
• Start date: April 1, 2016
• Est. completion date: April 12, 2017

Study information

• Verified date: May 2017
• Source: United Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 12, 2017
• Est. primary completion date: January 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Dietary Supplement:
• Thickened infant formula

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
United Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of regurgitation per day		14 days
Secondary	Regurgitation score assessed through Vandenplas score		14 and 90 days
Secondary	Stools frequency over 72h		14 and 90 days
Secondary	Stools consistency assessed through Bristol Stool form Scale		14 and 90 days
Secondary	Weight expressed in z scores according to the WHO Child Growth Standards		90 days
Secondary	Height expressed in z scores according to the WHO Child Growth Standards		90 days
Secondary	BMI expressed in z scores according to the WHO Child Growth Standards		90 days
Secondary	Head circumference expressed in z scores according to the WHO Child Growth Standards		90 days