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OpenTrials
Completed

NCT Number: NCT06273371

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

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.

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Key information

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Quirónsalud de Córdoba, Córdoba, Andalusia, Spain

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Patients under the age of 1 year at the time of cow's milk protein allergy diagnosis.
  • Patients taken Damira 2000 for at least 4 months at the time of data extraction.
  • 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

  • Patients who used other infant formulae or breast milk in addition to the study product of interest during the retrospective study period.
  • Premature children with a low birth-weight (<2.5 kg).
  • Patients diagnosed with a metabolic condition that impacts development and growth.
  • 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.

Treatment and study plan

Damira 2000 Infant formula

Other

100% extensive casein hydrolysate Infant formula

Primary outcomes

  1. Tolerance

    Time frame: Day 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 outcomes

  1. Weight

    Time frame: V1, V2 (4 months)

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

  2. Height

    Time frame: V1, V2 (4 months)

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

  3. Weight for height and BMI

    Time frame: V1, 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).

  4. Head circumference

    Time frame: V1, 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.

Sponsors and collaborators

Lead sponsor

Lactalis

Industry

Registry information

Acronym: DELISA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2024
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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