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RECRUITING
NCT04358146
NA

Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)

Sponsor: United Pharmaceuticals

View on ClinicalTrials.gov

Summary

The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.

Official title: Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial

Key Details

Gender

All

Age Range

2 Weeks - 4 Months

Study Type

INTERVENTIONAL

Enrollment

346

Start Date

2023-03-17

Completion Date

2026-12-03

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

OTHER

Experimental Infant formula

Exclusive formula feeding with the new infant formula thickened with fibers

OTHER

Infant formula thickened with locust bean gum

Exclusive formula feeding with the formula thickened with locust bean

Locations (12)

Center_14

Namur, Belgium

Center_15

Thuin, Belgium

Center_09

Castelnau-le-Lez, France

Center_02

Étampes, France

Center_05

Libourne, France

Centre_10

Maromme, France

Center_16

Nice, France

Center_08

Vincennes, France

Center_01

Athens, Greece

Center_11

Thessaloniki, Greece

Center_12

Naples, Italy

Center_13

Naples, Italy