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

Cow's Milk Protein Allergy Clinical Trial

— DELISA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06273371
• Other study ID #: DELISA2023
• Status: Completed
• Start date: December 12, 2023
• Est. completion date: December 21, 2023

Study information

• Verified date: February 2024
• Source: Lactalis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Gender: All
• Age group: 0 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Protein Allergy
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• Damira 2000 Infant formula
100% extensive casein hydrolysate Infant formula

Locations

Country	Name	City	State
Spain	Hospital Quirónsalud de Córdoba	Córdoba	Andalucia
Spain	Clínica privada Dr. Romera	Madrid
Spain	Fundación Jiménez Día	Madrid
Spain	Hospital Materno infantil de Ourense	Orense	Galicia
Spain	H. Clínico de Santiago	Santiago De Compostela	Galicia
Spain	H. Virgen del Rocío	Sevilla	Andalucia
Spain	H. Virgen Macarena	Sevilla	Andalucia
Spain	Instituto Hispalense de pediatría	Sevilla	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Lactalis

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance	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.	Day 0 : V0 First visit to the hospital
Secondary	Weight	To evaluate the effect of Damira 2000 on growth outcomes using weight and the related Z-scores weight-for-age (WAZ)	V1, V2 (4 months)
Secondary	Height	To evaluate the effect of Damira 2000 on growth outcomes using height and the related Z-scores height-for-age (HAZ).	V1, V2 (4 months)
Secondary	Weight for height and BMI	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).	V1, V2, (4 months)
Secondary	Head circumference	To evaluate the effect of Damira 2000 on growth outcomes using Head circumference and the related Z-Score Head circumference for age.	V1, V2 (4 months)