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TerminatedNCT06204770PEACEUpdated Apr 1, 2025

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

A Phase 4 interventional study of extensive hydrolyzed protein formula in Mild to Moderate Cows' Milk Protein Allergy, sponsored by Danone Specialized Nutrition Indonesia. Terminated at 5 sites in Indonesia. Open to participants aged 3 Months to 11 Months. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Danone Specialized Nutrition Indonesia (part of Danone) · Phase 4, Interventional, and Other

Why this study was terminated
Study was discontinued following the death of the Principal investigator

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2023, registered Dec 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
3 Months to 11 Months
Sex
All
01

Study 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

Read 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, 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.
02

Conditions studied

  • Mild to Moderate Cows' Milk Protein Allergy
03

In context

Lead sponsor

Danone Specialized Nutrition Indonesia is the lead sponsor of 3 studies on the registry; none are open to participants now.

Browse Danone Specialized Nutrition Indonesia studies →All Danone studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 11 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. 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.
  3. 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.
  4. Subject willing to stop any other formula while participating in this study
  5. Subject willing to adhere to the investigator's prescription for daily IP consumption during the study.
  6. 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).
  7. 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).
  8. At the screening visit, the patient's SBS score must be minimum 1.

Exclusion criteria

Exclusion Criteria:

  1. Pediatric patients who have other immunologic disorders history.
  2. Pediatric patients with congenital metabolic disorders, anatomic abnormalities, celiac disease, pancreatic insufficiency (cystic fibrosis), lactose intolerance, non-allergic gastro esophageal reflux disease, , and infection (Differential Diagnosis).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    groups of infants with CMPA

    Administered treatment for 4 weeks during intervention period.

    Other: extensive hydrolyzed protein formula

Interventions

  • Otherextensive 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)

06

What researchers measure

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

    Time frame: during the study period 28 days

Secondary outcomes

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

    Safety is measured by the number of participants with treatment-related adverse event as assessed by CTCAE v.5.0

    Time frame: during the study period 28 days

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

    Efficacy is measured by Symptom-Based Score (SBS) Questionnaire that was developed by Vanderplas, et. al (2013), with range score varies from 0 to 33. NR Pepti is determined to have efficacy if, during the 28 days of formula ingestion, there is ≥50% decrease of SBS score in all of enrolled subjects compared to baseline.

    Time frame: during the study period 28 days

07

Study locations

5 sites
  • Prof. Dr. dr. Zakiudin Munasir, Sp.A (K)'s private clinic
    Tangerang, Banten, Indonesia
  • Siloam Hospital Lippo Vilage
    Tangerang, Banten, Indonesia
  • dr. Martani Widjajanti Sukarlan, Sp.A (K)'s private clinic
    Jakarta, DKI Jakarta, Indonesia
  • RSUPN Dr. Cipto Mangunkusumo Kencana and Kiara
    Jakarta, DKI Jakarta, Indonesia
  • Hermina Hospital Depok
    Depok, West Java, Indonesia
08

References and documents

Individual participant data

Plan to share: No — will be discussed with principal investigator

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2023 to primary completion in Jan 2024, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2023
First posted
Jan 12, 2024
StartActual
Jul 14, 2023
Primary completionActual
Jan 17, 2024
CompletionActual
Jan 31, 2024
Last update
Apr 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06204770
Lead sponsor
Danone Specialized Nutrition Indonesia
Responsible party
Sponsor
First posted
Jan 12, 2024
Start date
Jul 14, 2023
Primary completion
Jan 17, 2024
Completion
Jan 31, 2024
Last update
Apr 1, 2025

Study contacts

Nia Kurniati, PhD
principal investigator · Pediatric Department, Faculty of Medicine, Universitas Indonesia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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