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Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain

Completed
Conditions
Cow's Milk Protein Allergy
Registration Number
NCT06273371
Lead Sponsor
Lactalis
Brief Summary

Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is indicated for allergy/intolerance to cow's milk proteins, atopic dermatitis secondary to CMPA, intestinal malabsorption processes and prevention of allergy/intolerance to cow's milk proteins.The study aimed at evaluating the tolerance of Damira 2000 in a cohort of children with CMPA.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
61
Inclusion Criteria
  1. Patients with a diagnosis of allergy to cow's milk protein (CMPA): either confirmed through a placebo-controlled food challenge (DBPCFC) or highly suspected based on specific suggestive symptoms;
  2. Patients under the age of 1 year at the time of cow's milk protein allergy diagnosis.
  3. Patients taken Damira 2000 for at least 4 months at the time of data extraction.
  4. Patients with information available on child growth (weight and height) and the following anthropometric indices at diagnosis and for at least 2 follow-up visits after first hospital visit/4 months*: Z-scores for weight-for-age (WAZ), height-for-age (HAZ), weight-for-height (WHZ) and body mass index (BMI)-for-age (BAZ).
Exclusion Criteria
  1. Patients who used other infant formulae or breast milk in addition to the study product of interest during the retrospective study period.
  2. Premature children with a low birth-weight (<2.5 kg).
  3. Patients diagnosed with a metabolic condition that impacts development and growth.
  4. Patients diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the investigator could potentially interfere with the aim of the study.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ToleranceDay 0 : V0 First visit to the hospital

The good tolerance of the currently on the market Damira 2000 formula will be evaluated by the number and percentage of patients with no (=0) immediate allergic reactions or intestinal reactions.

Immediate reactions are defined as those allergic reactions occurring within 1 hour after intake.

Intestinal reactions: delayed reactions (develop after ≥ 2 hours of consumption) involving gastrointestinal (GI) tract.

Secondary Outcome Measures
NameTimeMethod
WeightV1, V2 (4 months)

To evaluate the effect of Damira 2000 on growth outcomes using weight and the related Z-scores weight-for-age (WAZ)

HeightV1, V2 (4 months)

To evaluate the effect of Damira 2000 on growth outcomes using height and the related Z-scores height-for-age (HAZ).

Weight for height and BMIV1, V2, (4 months)

To evaluate the effect of Damira 2000 on growth outcomes using height and weight to calculate the Z-score weight-for-height (WHZ) and BMI for age (BAZ).

Head circumferenceV1, V2 (4 months)

To evaluate the effect of Damira 2000 on growth outcomes using Head circumference and the related Z-Score Head circumference for age.

Trial Locations

Locations (8)

Hospital Quirónsalud de Córdoba

🇪🇸

Córdoba, Andalucia, Spain

H. Virgen del Rocío

🇪🇸

Sevilla, Andalucia, Spain

H. Virgen Macarena

🇪🇸

Sevilla, Andalucia, Spain

Instituto Hispalense de pediatría

🇪🇸

Sevilla, Andalucia, Spain

Hospital Materno infantil de Ourense

🇪🇸

Orense, Galicia, Spain

H. Clínico de Santiago

🇪🇸

Santiago De Compostela, Galicia, Spain

Clínica privada Dr. Romera

🇪🇸

Madrid, Spain

Fundación Jiménez Día

🇪🇸

Madrid, Spain

Hospital Quirónsalud de Córdoba
🇪🇸Córdoba, Andalucia, Spain

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