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

NCT04358146 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux in Children

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

Sponsors & Collaborators

  • Statitec

    collaborator INDUSTRY

  • United Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-17
Primary Completion
2026-12-03
Completion
2026-12-03

Countries

  • Belgium
  • France
  • Greece
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358146 on ClinicalTrials.gov