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NCT Number: NCT07711938

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

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

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Key information

Conditions

Cow Milk Protein Allergy

Age range

29 day–22 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

New generation eHF

Dietary Supplement

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

Commercial eHF

Dietary Supplement

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

Primary outcomes

  1. Weight Gain Over 16 Weeks

    Time frame: 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.

Secondary outcomes

  1. Incidence of Adverse Events of Special Interest (AESIs)

    Time frame: 52 weeks

    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).

  2. Growth Parameters: Weight

    Time frame: 52 weeks

    The growth by body weight (in g) of infants over 52 weeks.

  3. Growth Parameters: Length

    Time frame: 52 weeks

    The growth by body length (in cm) of infants over 52 weeks

  4. Quality of Life Scores (ITQOL)

    Time frame: 52 weeks

    Quality of life over 52-weeks assessed by validated Quality of Life (QoL) scale: Infant and Toddler Quality of Life [ITQOL]

    Minimum score: 0 Maximum score: 100 Interpretation: Higher scores indicate better health-related quality of life, better functioning, or less negative impact on the child/family (depending on the specific domain). A score of 0 represents the worst health/status, while 100 represents the best health/status

  5. Stool Frequency and Stool Characteristics (BITSS)

    Time frame: 52 weeks

    Stool frequency and characteristics over 52 weeks based on Brussels Infant and Toddler Stool Scale (BITSS).

    Scale categories: 7 stool photographs corresponding to stool consistency types

    BITSS photographs are often grouped into:

    Hard: Types 1-3 Formed: Type 4 Loose: Types 5-6 Watery: Type 7

    Interpretation:

    Lower categories (1-3): harder stools, potentially associated with constipation.

    Middle category (4): formed/normal stool consistency. Higher categories (5-7): increasingly loose to watery stools, potentially associated with diarrhea.

  6. Resolution of CMPA-Related Symptoms

    Time frame: 52 weeks

    Rate of adequate clinical response and time to symptom resolution of CMPA-related symptoms (in days) collected on patient-reported outcome tool (PRO) based on parent(s)/legally authorized representative(s) (LAR) report.

  7. Formula intake compliance

    Time frame: 52 weeks

    Formula intake (in ml) compliance (number of feeds per day) based on parent(s)/LAR report records collected via electronic data capture (EDC)/interactive response technology (IRT).

  8. Healthcare resources utilization

    Time frame: 52 weeks

    Healthcare Resources Utilization (HCRU) over the 52-week intervention period, based on parent(s)/LAR report and medical records (such as: number of hospitalizations, number of unscheduled emergency department attendances, general practitioner/pediatrician visits)

  9. Growth Parameters: Head Circumference

    Time frame: 52 weeks

    The growth by head circumference (in cm) of infants over 52 weeks

  10. Quality of Life Scores (FLIP)

    Time frame: 52 weeks

    Quality of life over 52-weeks assessed by validated QoL scale: Food hypersensitivity family Impact [FLIP]

    Lower categories (1-3): harder stools, potentially associated with constipation.

    Middle category (4): formed/normal stool consistency. Higher categories (5-7): increasingly loose to watery stools, potentially associated with diarrhea.

  11. Resolution of Cow Milk Protein Allergy (CMPA)-Related Symptoms

    Time frame: 52 weeks

    Rate of adequate clinical response and time to symptom resolution of CMPA-related symptoms (in days) collected on Scoring Atopic Dermatitis Eczema Score (SCORAD) Minimum score: 0 Maximum score: 103 Interpretation: Higher scores indicate more severe eczema and therefore a worse outcome. Lower scores indicate less severe disease and a better outcome

  12. Resolution of CMPA-Related Symptoms

    Time frame: 52 weeks

    Rate of adequate clinical response and time to symptom resolution of CMPA-related symptoms (in days) collected on Infant Gastrointestinal Symptom Questionnaire (IGSQ) Minimum score: 13 Maximum score: 65 Interpretation: Higher scores indicate more gastrointestinal symptoms and poorer feeding tolerance (worse outcome). Lower scores indicate fewer GI symptoms and better tolerance.

  13. Resolution of CMPA-Related Symptoms

    Time frame: 52 weeks

    Rate of adequate clinical response and time to symptom resolution of CMPA-related symptoms (in days) collected on Cow's Milk-Related Symptom Score (CoMiSS).

    Minimum score: 0 Maximum score: 33 Interpretation: Higher scores indicate more severe cow's milk-related symptoms and therefore a worse outcome. Lower scores indicate fewer symptoms and a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Ingrassia

CONTACT

[email protected]

+41 21 785 92 23

Kamila Laskowska

CONTACT

[email protected]

41 21 785 87 32

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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