CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula

Nestlé

Status: Terminated

Conditions: Cow Milk Protein Allergy

Treatments: Dietary Supplement: New generation eHF; Dietary Supplement: Commercial eHF

Study type: Interventional

Funder types: Industry

Identifiers

NCT06830681

2317.CLI

Details and patient eligibility

About

CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula

Enrollment: 4 patients

Sex: All

Ages: 4 to 22 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups

Test Formula

Experimental group

Description:

New generation eHF

Treatment:

Dietary Supplement: New generation eHF

Control Formula

Active Comparator group

Description:

Commercial eHF

Treatment:

Dietary Supplement: Commercial eHF