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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Weeks - 22 Weeks
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06830681
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Société des Produits Nestlé (SPN)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow Milk Protein Allergy

Arms & Interventions

Arms

Experimental: Test Formula

New generation eHF

Active Comparator: Control Formula

Commercial eHF

Interventions

Dietary Supplement: - New generation eHF

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

Dietary Supplement: - Commercial eHF

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Grupo Pediátrico Uncibay, Málaga, Spain

Status

Recruiting

Address

Grupo Pediátrico Uncibay

Málaga, ,

Site Contact

Manuel Baca Cots

[email protected]

+41219249825

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