Status:
TERMINATED
Tolerance of Extensive Hydrolyzed Whey Protein Milk Among Infant With Mild to Moderate CMPA
Lead Sponsor:
Danone Specialized Nutrition Indonesia
Conditions:
Mild to Moderate Cows' Milk Protein Allergy
Eligibility:
All Genders
3-11 years
Phase:
PHASE4
Brief 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...
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, Tanger...
Eligibility Criteria
Inclusion
- Pediatric patients (3-11 months) that are diagnosed with mild and moderate CMPA by HCPSs (Health Care Professional) having ≥ 1 symptoms such as:
- Gastrointestinal: Frequent regurgitation, Vomiting, Diarrhea, Constipation, Blood in stool without failure to thrive
- Dermatological: Atopic dermatitis, Swelling of lips or eyelids, Urticaria unrelated to acute infections, drug intake, or other causes
- Respiratory: Runny nose, Recurrent otitis media, Chronic cough, Broncho-constriction unrelated to infection
- General: Persistent distress, Colic (≥ 3 h/day wailing/irritable) over a period of \> 3 weeks CMPA patients who have another food allergy are still allowed to participate in this study.
- 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).
- At the screening visit, the patient's SBS score must be minimum 1.
Exclusion
- Pediatric patients who have other immunologic disorders history.
- Pediatric patients with congenital metabolic disorders, anatomic abnormalities, celiac disease, pancreatic insufficiency (cystic fibrosis), lactose intolerance, non-allergic gastro esophageal reflux disease, malignancy, and infection (Differential Diagnosis).
Key Trial Info
Start Date :
July 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06204770
Start Date
July 14 2023
End Date
January 31 2024
Last Update
April 1 2025
Active Locations (5)
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1
Prof. Dr. dr. Zakiudin Munasir, Sp.A (K)'s private clinic
Tangerang, Banten, Indonesia
2
Siloam Hospital Lippo Vilage
Tangerang, Banten, Indonesia
3
dr. Martani Widjajanti Sukarlan, Sp.A (K)'s private clinic
Jakarta, DKI Jakarta, Indonesia
4
RSUPN Dr. Cipto Mangunkusumo Kencana and Kiara
Jakarta, DKI Jakarta, Indonesia