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Not yet recruiting NCT07711938

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

No phase Interventional Cow Milk Protein Allergy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: New generation eHF, Commercial eHF.
Who it may be relevant to
Registry conditions: Cow Milk Protein Allergy. Basic parameters: 29 Days — 22 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Controlled Study to Compare Growth, Tolerability, and Safety of a Novel, Extensively Hydrolyzed Formula (eHF) Versus a Standard eHF in Full Term Infants With Cow's Milk Protein Allergy (CMPA)

Overview

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

Interventions

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

Primary outcome measures

  • Weight Gain Over 16 Weeks [Time frame: 16 weeks]
Secondary outcome measures (12)
  • Incidence of Adverse Events of Special Interest (AESIs) [Time frame: 52 weeks]
  • Growth Parameters: Weight [Time frame: 52 weeks]
  • Growth Parameters: Length [Time frame: 52 weeks]
  • Quality of Life Scores (ITQOL) [Time frame: 52 weeks]
  • Stool Frequency and Stool Characteristics (BITSS) [Time frame: 52 weeks]
  • Resolution of CMPA-Related Symptoms [Time frame: 52 weeks]
  • Formula intake compliance [Time frame: 52 weeks]
  • Healthcare resources utilization [Time frame: 52 weeks]
  • Growth Parameters: Head Circumference [Time frame: 52 weeks]
  • Quality of Life Scores (FLIP) [Time frame: 52 weeks]
  • Resolution of Cow Milk Protein Allergy (CMPA)-Related Symptoms [Time frame: 52 weeks]
  • Resolution of CMPA-Related Symptoms [Time frame: 52 weeks]

Eligibility criteria

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.
  • Infants whose parent(s)/LAR cannot be expected to comply with study procedures.
  • Currently participating or having participated in another clinical study since birth.
  • Infants with a history of confirmed food protein induced enterocolitis syndrome due to other foods than CMP or Heiner syndrome.
  • Infants with history of oral immunotherapy for CMPA.
  • Diagnosed eosinophilic esophagitis.
  • Received systemic oral or injected corticosteroids for more than 3 days (72 hours) within 2 weeks prior to the Screening Visit (topical corticosteroids allowed).
  • Received systemic antibiotics within 1 week prior to Screening Visit (topical antibiotics, e.g., mupirocin allowed).
  • Infants who are currently receiving treatment with immunomodulators (immunoglobulins, allergen extracts, or similar) or immuno-suppressants (azathioprine, cyclosporine or similar) within 2 weeks of Screening Visit (topical cyclosporine, tacrolimus, pimecrolimus or similar topical eczema treatments allowed), as well as infants with immune disorders which can compromise the immune function.
  • Infants with a 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 participant's ability to participate in the study (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine or metabolic disorders, malignancy, major physical impairment, immunodeficiency, infectious disease or abnormal laboratory results as per the investigator's judgment).
  • Parent(s)/LAR being in any relationship or dependency with the sponsor, and/or the investigator, and/or study staff.
  • Underage parents (under 18 years old).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07711938 · 2508.CLI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗