TerminatedNot Applicable

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

Stopped: Business decision/strategic reason

Spain4 participantsStarted 2025-01-07

Plain-language summary

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

Age range4 Weeks – 22 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Growth

Timeframe: 16 weeks

NCT IDNCT06830681

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-23