CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula (CMPA-GO)

A Growth, Tolerability, and Safety Study of a Novel Extensively Hydrolyzed Formula (eHF) in Infants With Cow's Milk Protein Allergy (CMPA)

CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula

Study Overview

• Status: Terminated
• Conditions: Cow Milk Protein Allergy
• Intervention / Treatment: Dietary supplement: New generation eHF; Dietary supplement: Commercial eHF

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain
    • Grupo Pediatrico Uncibay

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. Infant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks).
4. Not breastfed at time of Screening Visit.
5. 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. Demonstrated chronic malabsorption not due to CMPA.
3. History of anaphylaxis to CMP.
4. Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
5. Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
6. History of any immunotherapy for CMPA.
7. 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 subject's ability to participate in the study.

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
Growth	To assess the growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants fed with the Test formula, compared to infants fed with the Control formula over 16 weeks of formula use.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)	Data gathered by monitoring adverse events with relatedness, seriousness, and severity over 52 weeks.	52 weeks
Tolerability	Tolerability of the formulas assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) and and Cow's Milk-related Symptom Score (CoMiSS®).	52 weeks
Growth	The growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants over 52 weeks.	52 weeks
Stool frequency and characteristics	Stool frequency and characteristics over 52 weeks based on Brussels Infant and Toddler Stool Scale (BITSS).	52 weeks
Quality of life	Quality of life over 52-weeks assessed by by 2 validated QoL scales ("Infant and Toddler Quality of Life" [ITQOL] and 'Food hypersensitivity famiLy ImPact' [FLIP]).	52 weeks

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Actual): May 23, 2025
• Study Completion (Actual): June 23, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Food Hypersensitivity; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: 2317.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