NCT06204770

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

a Prospective, Single-arm, Symptom-based Score, to Evaluate the Tolerance of Extensive Hydrolyzed Whey Protein Milk Intervention Among Infant With Mild to Moderate CMPA

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Danone Specialized Nutrition Indonesia · Industry
• Sex: All
• Age: 3 Months – 11 Months
• Healthy volunteers: Not accepted

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

Detailed description

This study will be carried out by a principal investigator and co-investigators, all of whom will collaborate with doctors from Indonesian Pediatric Society (IDAI) in the Jakarta, Bogor, Depok, Tangerang and Bekasi (Jabodetabek) area. The following is the flow of subject recruitment: 1. Investigators will make direct contact with their patients and also recruit subjects through referral from IDAI pediatricians in the Jabodetabek area who have potential eligible patients for this study. 2. The media to be used in the recruitment are leaflets which firstly will be reviewed by the Ethics Committee. The leaflet will summarize information regarding the study and the referral procedures. 3. If the pediatrician has a subject that meets the eligibility criteria, they may reach the Principal Investigator (PI) or Study Team. 4. The Study Team will arrange discussion between pediatricians and the study team. The investigators will then carry out a brief assessment on the subject's inclusion and exclusion criteria. 5. If declared feasible and IDAI's pediatricians agree to refer their subject(s), the study team will coordinate with the pediatricians about their status in the study, and will coordinate with the subject to assign them to one of the listed sites run by investigators. 6. After the subject is completely transferred to the study site, the investigator will perform an informed consent process and continue by assessing the subject's inclusion and exclusion criteria on site. 7. If the assessment passed, the study team can start to intervene on the subject according to the provisions of the protocol. 8. During the intervention period, the study team will be assisted by Study Coordinator (SC) in maintaining the availability of milk investigational products for the subjects.

Conditions

• Mild to Moderate Cows' Milk Protein Allergy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-07-14
• Primary completion: 2024-01-17
• Completion: 2024-01-31
• First posted: 2024-01-12
• Last updated: 2025-04-01

Locations

5 sites across 1 country: Indonesia