Growth And Safety Outcomes In Infants With Cow´s Milk Pro... | NCT07711938

NCT07711938

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Formula	Experimental	New generation eHF	Dietary Supplement: New generation eHF
Control Formula	Active Comparator	Commercial eHF	Dietary Supplement: Commercial eHF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
New generation eHF	Dietary Supplement	New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.	Test Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight Gain Over 16 Weeks	To demonstrate non-inferiority in growth in infants fed with the Test formula, compared to infants fed with the Control formula over the first 16 weeks of formula intake.	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events of Special Interest (AESIs)	To evaluate the safety and tolerability of the Test formula, including effects on "adverse events of special interest (AESIs)", which include lower respiratory tract infections (LRTIs), upper respiratory tract infections (URTIs), ear infections/otitis media, gastrointestinal infections and other viral or bacterial infections including urinary tract infections (UTIs).

Eligibility Module

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).

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Kamila Laskowska	Contact	41 21 785 87 32		kamila.laskowska@rd.nestle.com
Giulia Ingrassia	Contact	+41 21 785 92 23		giuliamarialaura.ingrassia@rd.nestle.com