Tolerance of Extensive Hydrolyzed Whey Protein Milk Among Infant With Mild to Moderate CMPA (NCT06204770) | Clinical Trial Compass
TerminatedPhase 4
Tolerance of Extensive Hydrolyzed Whey Protein Milk Among Infant With Mild to Moderate CMPA
Stopped: Study was discontinued following the death of the Principal investigator
Indonesia15 participantsStarted 2023-07-14
Plain-language 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
Who can participate
Age range3 Months – 11 Months
SexALL
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Inclusion criteria
✓. Pediatric patients (3-11 months) that are diagnosed with mild and moderate CMPA by HCPSs (Health Care Professional) having ≥ 1 symptoms such as:
✓. Subjects consumed only formula or mixed feeding (breast milk and formula milk, with maximum two times of breastfeeding in a day). Subject consuming weaning or complementary food is still allowed.
✓. Mothers with mix-fed children willing to eliminate consuming any cow's milk product during the mix-fed period to avoid allergy onset due to breast milk.
✓. Subject willing to stop any other formula while participating in this study
✓. Subject willing to adhere to the investigator's prescription for daily IP consumption during the study.
✓. Every patient that has been diagnosed with symptom-based CMPA must also have a record of being treated by consultant's ≥ 2 times for the past 2 weeks before screening (the 2nd consultation could also be on the screening visit).
✓. Every patient needs to have at least 1 diagnosis result to confirm symptom-based CMPA. (Previous diagnosis methods could be used if available. If previous result is not available, HCP will perform one of the method mention in the protocol, the chosen diagnosis method is given to the HCP to be determined).
✓
What they're measuring
1
evaluate tolerance of NR Pepti among infants with mild to moderate CMPA.