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NCT06204770: PEACE

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

Terminated Phase 4 Last updated 1 April 2025
What this trial tests

Phase 4 trial testing extensive hydrolyzed protein formula in Mild to Moderate Cows' Milk Protein Allergy in 15 participants. Terminated before completion.

Timeline
14 July 2023
Primary endpoint
17 January 2024
31 January 2024

Quick facts

Lead sponsorDanone Specialized Nutrition Indonesia
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment15
Start date14 July 2023
Primary completion17 January 2024
Estimated completion31 January 2024
Sites5 locations across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Danone Specialized Nutrition Indonesia

Who can join

Adults 3 Months to 11 Months, any sex, with Mild to Moderate Cows' Milk Protein Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Danone Specialized Nutrition Indonesia trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06204770.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing