NCT07711938

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026May 2029

First Submitted

Initial submission to the registry

June 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2029

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

June 22, 2026

Last Update Submit

July 16, 2026

Conditions

Cow Milk Protein Allergy

Outcome Measures

Primary Outcomes (1)

  • 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 (13)

  • Incidence of Adverse Events of Special Interest (AESIs)

    52 weeks

  • Growth Parameters: Weight

    52 weeks

  • Growth Parameters: Length

    52 weeks

  • Quality of Life Scores (ITQOL)

    52 weeks

  • Stool Frequency and Stool Characteristics (BITSS)

    52 weeks

  • +8 more secondary outcomes

Study Arms (2)

Test Formula

EXPERIMENTAL

New generation eHF

Dietary Supplement: New generation eHF

Control Formula

ACTIVE COMPARATOR

Commercial eHF

Dietary Supplement: Commercial eHF

Interventions

New generation eHFDIETARY_SUPPLEMENT

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

Test Formula
Commercial eHFDIETARY_SUPPLEMENT

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

Control Formula

Eligibility Criteria

Age29 Days - 22 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Kamila Laskowska

CONTACT

41 21 785 87 32kamila.laskowska@rd.nestle.com

Giulia Ingrassia

CONTACT

+41 21 785 92 23giuliamarialaura.ingrassia@rd.nestle.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

July 17, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

May 30, 2029

Last Updated

July 17, 2026

Record last verified: 2026-07