Trials Sponsors Conditions Drugs Pricing

You may not qualify if:

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).

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Test Formula

Control Formula

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Test Formula

Control Formula

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record