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

NCT06204770 | Terminated Phase 4

• 1 other identifier: 180923
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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 main questions it aims to answer are:

1. 1.Is NR Pepti tolerable among infants with mild to moderate CMPA?
2. 2.Is NR Pepti safe and effective among infants with mild to moderate CMPA?

Conditions

Mild to Moderate Cows' Milk Protein Allergy

Outcome Measures

Primary Outcomes (1)

• evaluate tolerance of NR Pepti among infants with mild to moderate CMPA.

  NR Pepti is determined to have tolerance if, during the 28 days of formula ingestion, there is no new symptom or developing allergic reaction as assessed by Symptom-Based Score Questionnaire that was developed by Vanderplas, et. al (2013) in 90% of the population compared to baseline. New symptom is described as CMPA symptoms that appear in the SBS questionnaire during the study while not being appeared in the baseline. Developing allergy reaction is describe as increase of existing CMPA symptom grade as assessed using SBS questionnaire during the study compared to the baseline

  during the study period 28 days

Secondary Outcomes (2)

• evaluate the safety of NR Pepti among infants with mild to moderate CMPA.

  during the study period 28 days

• evaluate the efficacy of NR Pepti among infants with mild to moderate CMPA.

  during the study period 28 days

Study Arms (1)

groups of infants with CMPA

EXPERIMENTAL

Administered treatment for 4 weeks during intervention period.

Other: extensive hydrolyzed protein formula

Interventions

extensive hydrolyzed protein formula OTHER

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)

groups of infants with CMPA

Eligibility Criteria

• Age: 3 Months - 11 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Danone Specialized Nutrition Indonesia: lead

Study Sites (5)

Prof. Dr. dr. Zakiudin Munasir, Sp.A (K)'s private clinic

Tangerang, Banten, Indonesia

Location

Siloam Hospital Lippo Vilage

Tangerang, Banten, Indonesia

Location

dr. Martani Widjajanti Sukarlan, Sp.A (K)'s private clinic

Jakarta, DKI Jakarta, Indonesia

Location

RSUPN Dr. Cipto Mangunkusumo Kencana and Kiara

Jakarta, DKI Jakarta, Indonesia

Location

Hermina Hospital Depok

Depok, West Java, Indonesia

Location

Study Officials

• Nia Kurniati, PhD

  Pediatric Department, Faculty of Medicine, Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be asked to use NR Pepti as part their management of mild to moderate Cow's milk protein allergy

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 12, 2024
• Study Start: July 14, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 31, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (5)