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

United Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Dietary Supplement: New thickened formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02425423

2013-01-SONAR

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: Under 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

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

New thickened infant formula

Experimental group

Treatment:

Dietary Supplement: New thickened formula