MedTrace Logo

Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.

NCT06633250 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-12-26

No results posted yet for this study

Summary

The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).

Conditions

  • Cow Milk Protein Allergy

Interventions

OTHER

Test Formula

Hydrolyzed rice protein formula

OTHER

Control Formula

Commercially available extensively hydrolyzed cow's milk formula

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-25
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Germany
  • Italy
  • Poland

Study Locations

More Related Trials

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 NCT06633250 on ClinicalTrials.gov