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

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cow Milk Protein Allergy
• Intervention / Treatment: Dietary supplement: New generation eHF; Dietary supplement: Commercial eHF

• Study Type: Interventional
• Enrollment (Estimated): 410
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamila Laskowska; Phone Number: 41 21 785 87 32; Email: kamila.laskowska@rd.nestle.com
• Study Contact Backup: Name: Giulia Ingrassia; Phone Number: +41 21 785 92 23; Email: giuliamarialaura.ingrassia@rd.nestle.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Full-term infant(gestational age ≥37 weeks and ≤42 weeks).
2. Birth weight ≥2500 g and ≤4500 g.
3. Parent(s)/LAR deemed able to provide written informed consent for participation of their infant in the study (in the opinion of the investigator).
4. Participant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks) at time of enrollment.
5. Not breastfed at time of Screening Visit.
6. 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. 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).
3. Demonstrated chronic malabsorption not due to CMPA.
4. History of severe anaphylaxis to CMP.
5. Infants whose parent(s)/LAR cannot be expected to comply with study procedures.
6. Currently participating or having participated in another clinical study since birth.
7. Infants with a history of confirmed food protein induced enterocolitis syndrome due to other foods than CMP or Heiner syndrome.
8. Infants with history of oral immunotherapy for CMPA.
9. Diagnosed eosinophilic esophagitis.
10. Received systemic oral or injected corticosteroids for more than 3 days (72 hours) within 2 weeks prior to the Screening Visit (topical corticosteroids allowed).
11. Received systemic antibiotics within 1 week prior to Screening Visit (topical antibiotics, e.g., mupirocin allowed).
12. 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.
13. 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).
14. Parent(s)/LAR being in any relationship or dependency with the sponsor, and/or the investigator, and/or study staff.
15. Underage parents (under 18 years old).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Formula; New generation eHF	Dietary supplement: New generation eHF; New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.
Active Comparator: Control Formula; Commercial eHF	Dietary supplement: Commercial eHF; Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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).	52 weeks
Growth Parameters: Weight	The growth by body weight (in g) of infants over 52 weeks.	52 weeks
Growth Parameters: Length	The growth by body length (in cm) of infants over 52 weeks	52 weeks
Quality of Life Scores (ITQOL)	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	52 weeks
Stool Frequency and Stool Characteristics (BITSS)	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.	52 weeks
Resolution of CMPA-Related Symptoms	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.	52 weeks
Formula intake compliance	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).	52 weeks
Healthcare resources utilization	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)	52 weeks
Growth Parameters: Head Circumference	The growth by head circumference (in cm) of infants over 52 weeks	52 weeks
Quality of Life Scores (FLIP)	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.	52 weeks
Resolution of Cow Milk Protein Allergy (CMPA)-Related Symptoms	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	52 weeks
Resolution of CMPA-Related Symptoms	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.	52 weeks
Resolution of CMPA-Related Symptoms	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.	52 weeks

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): May 30, 2029

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2508.CLI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No