Growth and safety outcomes in infants with cow milk protein allergy using a new formula

A Growth, Tolerability, and Safety Study of a Novel Extensively Hydrolyzed Formula (eHF) in Infants With Cow's Milk Protein Allergy (CMPA)

This study is testing a new formula to see if it helps infants with cow milk protein allergy grow safely and feel better compared to a regular formula.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 460 (estimated)
• Ages: 4 Weeks to 22 Weeks
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Málaga)
• Trial ID: NCT06830681 on ClinicalTrials.gov

What this trial studies

This study evaluates the growth and safety outcomes in infants diagnosed with cow milk protein allergy (CMPA) who are fed a novel extensively hydrolyzed formula. The trial involves infants aged between 29 days and 5 months who have not been breastfed and have a history of allergic reactions to cow's milk. Participants will be monitored for their growth and any adverse effects while consuming the new formula compared to a commercial extensively hydrolyzed formula. The study aims to provide insights into the effectiveness of this new formula in managing CMPA in infants.

Who should consider this trial

Good fit: Ideal candidates for this study are full-term infants aged between 29 days and 5 months with a history of cow milk protein allergy.

Not a fit: Patients with a history of anaphylaxis to cow's milk or those who have previously used extensively hydrolyzed formulas for more than two weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective nutritional option for infants with cow milk protein allergy.

How similar studies have performed: Other studies have shown success with extensively hydrolyzed formulas in managing cow milk protein allergy, indicating that this approach is supported by prior research.

Eligibility criteria

Inclusion Criteria:

1. Full term infant (gestational age ≥37 weeks and ≤42 weeks).
2. Birth weight ≥2500 g and ≤4500 g.
3. Infant aged ≥29 days (\>4 weeks) and \<5 months (≤22 weeks).
4. Not breastfed at time of Screening Visit.
5. 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:

1. Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
2. Demonstrated chronic malabsorption not due to CMPA.
3. History of anaphylaxis to CMP.
4. Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
5. Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
6. History of any immunotherapy for CMPA.
7. Past or current disease or disorder which, in the opinion of the Investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the subject's ability to participate in the study.

Where this trial is running

Málaga

• Grupo Pediátrico Uncibay — Málaga, Spain (Recruiting)

Study contacts

• Study coordinator: Liljana Claret - Tournier Clinical Project Manager

Conditions Cow Milk Protein Allergy