Cow Milk Protein Allergy
Conditions
Brief summary
CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula
Interventions
DIETARY_SUPPLEMENTNew generation eHF
New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.
DIETARY_SUPPLEMENTCommercial eHF
Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 22 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth | 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool frequency and characteristics | 52 weeks | Stool frequency and characteristics over 52 weeks based on Brussels Infant and Toddler Stool Scale (BITSS). |
| Growth | 52 weeks | The growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants over 52 weeks. |
| Safety via reporting of adverse events (AEs) and serious adverse events (SAEs) | 52 weeks | Data gathered by monitoring adverse events with relatedness, seriousness, and severity over 52 weeks. |
| Tolerability | 52 weeks | Tolerability of the formulas assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) and and Cow's Milk-related Symptom Score (CoMiSS®). |
| Quality of life | 52 weeks | 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' \[FLIP\]). |
Countries
Spain
Outcome results
None listed