Mild to Moderate Cows' Milk Protein AllergyPhase 4PEACENCT06204770
Tolerance of Extensive Hydrolyzed Whey Protein Milk Among Infant With Mild to Moderate CMPA
A Phase 4 study testing extensive hydrolyzed protein formula in people with Mild to Moderate Cows' Milk Protein Allergy, run by Danone Specialized Nutrition Indonesia at 5 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 11 months
- Conditions the study is for
- Mild to Moderate Cows' Milk Protein Allergy
- What is being tested?
- extensive hydrolyzed protein formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesIndonesia
- Study dates
- 14 Jul 2023to 31 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Indonesia5 sites
Hermina Hospital Depok
Depok, West Java
dr. Martani Widjajanti Sukarlan, Sp.A (K)'s private clinic
Jakarta, DKI Jakarta
RSUPN Dr. Cipto Mangunkusumo Kencana and Kiara
Jakarta, DKI Jakarta
Prof. Dr. dr. Zakiudin Munasir, Sp.A (K)'s private clinic
Tangerang, Banten
Siloam Hospital Lippo Vilage
Tangerang, Banten
About this study
Official title: 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
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:
- Is NR Pepti tolerable among infants with mild to moderate CMPA?
- 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:
- 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.
- 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.
- If the pediatrician has a subject that meets the eligibility criteria, they may reach the Principal Investigator (PI) or Study Team.
- 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.
- 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.
- 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.
- If the assessment passed, the study team can start to intervene on the subject according to the provisions of the protocol.
- 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.
- Being tested
- extensive hydrolyzed protein formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extensive hydrolyzed protein formulaOther
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)
| Study group | Role | What they receive |
|---|---|---|
| groups of infants with CMPA | Experimental | Administered treatment for 4 weeks during intervention period. Receives: Other: extensive hydrolyzed protein formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the study period 28 days
Secondary outcomes (2)
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
Measured: during the study period 28 days
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.
Measured: during the study period 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start14 Jul 2023
- Primary completion17 Jan 2024
- Study completion31 Jan 2024
Why it stopped: Study was discontinued following the death of the Principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Cows' Milk Protein AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be asked to use NR Pepti as part their management of mild to moderate Cow's milk protein allergy
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Specialized Nutrition Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nia Kurniati, PhD, Principal investigator, Pediatric Department, Faculty of Medicine, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204770
- Sponsor's protocol ID
- 180923
- Acronym
- PEACE
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be discussed with principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06204770
- Acronym / sponsor ID
- PEACE / 180923
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was discontinued following the death of the Principal investigator
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Danone Specialized Nutrition IndonesiaIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is NR Pepti tolerable among infants with mild to moderate CMPA?
- 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:
- 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.
- 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.
- If the pediatrician has a subject that meets the eligibility criteria, they may reach the Principal Investigator (PI) or Study Team.
- 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.
- 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.
- 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.
- If the assessment passed, the study team can start to intervene on the subject according to the provisions of the protocol.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be asked to use NR Pepti as part their management of mild to moderate Cow's milk protein allergy
| Arm | Type | Receives |
|---|---|---|
| groups of infants with CMPA | Experimental | Other: extensive hydrolyzed protein formulaAdministered treatment for 4 weeks during intervention period. |
Who may qualify
- Ages
- 3 to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extensive hydrolyzed protein formulaNR 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) | Other | groups of infants with CMPA |
Primary outcome
evaluate tolerance of NR Pepti among infants with mild to moderate CMPA.
Time frame: during the study period 28 days
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
2 secondary outcomes
evaluate the safety of NR Pepti among infants with mild to moderate CMPA.
Time frame: during the study period 28 days
evaluate the efficacy of NR Pepti among infants with mild to moderate CMPA.
Time frame: during the study period 28 days
Results and safety
The study was stopped early (reason given: Study was discontinued following the death of the Principal investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. will be discussed with principal investigator
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nia Kurniati, PhD principal investigator
Pediatric Department, Faculty of Medicine, Universitas Indonesia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing extensive hydrolyzed protein formula in people with Mild to Moderate Cows' Milk Protein Allergy, run by Danone Specialized Nutrition Indonesia at 5 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was discontinued following the death of the Principal investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate tolerance of NR Pepti among infants with mild to moderate CMPA. (time frame: during the study period 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.