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NCT06204770: PEACE
Tolerance of Extensive Hydrolyzed Whey Protein Milk Among Infant With Mild to Moderate CMPA
Phase 4 trial testing extensive hydrolyzed protein formula in Mild to Moderate Cows' Milk Protein Allergy in 15 participants. Terminated before completion.
17 January 2024
Quick facts
| Lead sponsor | Danone Specialized Nutrition Indonesia |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 15 |
| Start date | 14 July 2023 |
| Primary completion | 17 January 2024 |
| Estimated completion | 31 January 2024 |
| Sites | 5 locations across Indonesia |
Drugs / interventions tested
- extensive hydrolyzed protein formula
Conditions studied
- Mild to Moderate Cows' Milk Protein Allergy — all drugs for Mild to Moderate Cows' Milk Protein Allergy →
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.
Verify or expand the search:
- PubMed search for NCT06204770
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other Danone Specialized Nutrition Indonesia trials
Trials by the same sponsor.
- NCT05489094 — The Impact of Nutrition Education and Milk Provision in Fueling the Progress of 1 - 3 Years Old Children · Phase 4 · unknown
- NCT05393934 — Growth Faltering Intervention Using Pediatric Nutritional Care (PNC) vs.PNC& FSMP · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06204770 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Danone Specialized Nutrition Indonesia
- Last refreshed: 1 April 2025
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