Study Stopped
Business decision/strategic reason
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)
1 other identifier
interventional
4
1 country
1
Brief Summary
CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
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 Start
First participant enrolled
January 7, 2025
CompletedFirst Submitted
Initial submission to the registry
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
February 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2025
CompletedJune 29, 2025
June 1, 2025
5 months
January 15, 2025
June 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)
52 weeks
Tolerability
52 weeks
Growth
52 weeks
Stool frequency and characteristics
52 weeks
Quality of life
52 weeks
Study Arms (2)
Test Formula
EXPERIMENTALNew generation eHF
Control Formula
ACTIVE COMPARATORCommercial eHF
Interventions
New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.
Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.
Eligibility Criteria
You may qualify if:
- Full term infant (gestational age ≥37 weeks and ≤42 weeks).
- Birth weight ≥2500 g and ≤4500 g.
- Infant aged ≥29 days (\>4 weeks) and \<5 months (≤22 weeks).
- 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.
- Demonstrated chronic malabsorption not due to CMPA.
- History of anaphylaxis to CMP.
- Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
- Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
- History of any immunotherapy for CMPA.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Grupo Pediátrico Uncibay
Málaga, Spain
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
January 15, 2025
First Posted
February 17, 2025
Study Start
January 7, 2025
Primary Completion
May 23, 2025
Study Completion
June 23, 2025
Last Updated
June 29, 2025
Record last verified: 2025-06