Not Yet RecruitingNot Applicable

Growth And Safety Outcomes In Infants With Cow´s Milk Protein Allergy (CMPA) Fed A Novel Extensively Hydrolyzed Formula (eHF)

410 participantsStarted 2026-07-01

Plain-language summary

Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.

Who can participate

Age range

29 Days – 22 Weeks

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

. Full-term infant(gestational age ≥37 weeks and ≤42 weeks).
. Birth weight ≥2500 g and ≤4500 g.
. Parent(s)/LAR deemed able to provide written informed consent for participation of their infant in the study (in the opinion of the investigator).
. Participant aged ≥29 days (\>4 weeks) and \<5 months (≤22 weeks) at time of enrollment.
. Not breastfed at time of Screening Visit.
. History of an immediate-type (IgE-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-IgE-mediated) CMPA.

Exclusion criteria

. Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
. Congenital illness or malformation that may affect growth, or significant pre-natal and/or serious post-natal disease other than CMPA before randomization (per investigator's medical decision).
. Demonstrated chronic malabsorption not due to CMPA.
. History of severe anaphylaxis to CMP.

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

Weight Gain Over 16 Weeks

Timeframe: 16 weeks

Trial details

NCT IDNCT07711938

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Kamila Laskowska

41 21 785 87 32 kamila.laskowska@rd.nestle.com

View on ClinicalTrials.gov More Cow Milk Protein Allergy trials