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Tolerance of Extensive Hydrolyzed Whey Protein Milk Among Infant With Mild to Moderate CMPA

NCT06204770 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-04-01

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the tolerance, safety and efficacy of Nutribaby Royal Pepti Junior (NR Pepti) among infants with mild to moderate Cow's Milk Protein Allergy (CMPA).

The main questions it aims to answer are:

1. Is NR Pepti tolerable among infants with mild to moderate CMPA?
2. Is NR Pepti safe and effective among infants with mild to moderate CMPA?

Participants will be asked to use NR Pepti as part their management of mild to moderate CMPA

Conditions

  • Mild to Moderate Cows' Milk Protein Allergy

Interventions

OTHER

extensive hydrolyzed protein formula

NR Pepti is infant formula for special medical purposes based on extensive hydrolyzed whey protein for infants aged 0-12 months. This milk is intended for cow's milk protein allergy. This product is lactose free with medium chain triglycerides (MCT)

Sponsors & Collaborators

  • Danone Specialized Nutrition Indonesia

    lead INDUSTRY

Principal Investigators

  • Nia Kurniati, PhD · Pediatric Department, Faculty of Medicine, Universitas Indonesia

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
11 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2024-01-17
Completion
2024-01-31

Countries

  • Indonesia

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 NCT06204770 on ClinicalTrials.gov