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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2025-06-23

Brief Summary

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

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Detailed Description

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Conditions

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Cow Milk Protein Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Test Formula

New generation eHF

Group Type EXPERIMENTAL

New generation eHF

Intervention Type DIETARY_SUPPLEMENT

New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.

Control Formula

Commercial eHF

Group Type ACTIVE_COMPARATOR

Commercial eHF

Intervention Type DIETARY_SUPPLEMENT

Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.

Interventions

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New generation eHF

New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.

Intervention Type DIETARY_SUPPLEMENT

Commercial eHF

Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

4 Weeks

Maximum Eligible Age

22 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No