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

United Pharmaceuticals

Status: Completed

Conditions: Gastroesophageal Reflux

Treatments: Dietary Supplement: Thickened infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02710955

2016-01-SWAN

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 1 week to 5 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Thickened infant formula

Experimental group

Treatment:

Dietary Supplement: Thickened infant formula