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 range

3 Months – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: during the study period 28 days

Trial details

NCT IDNCT06204770

SponsorDanone Specialized Nutrition Indonesia

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-17

View on ClinicalTrials.gov More Mild to Moderate Cows' Milk Protein Allergy trials

Plain-language summary

Who can participate

Age range

3 Months – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria