Damira 2000 Infant formula
Other100% extensive casein hydrolysate Infant formula
NCT Number: NCT06273371
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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Notify Me0 month–12 month
All sexes
Observational
Hospital Quirónsalud de Córdoba, Córdoba, Andalusia, Spain
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100% extensive casein hydrolysate Infant formula
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.
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)
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).
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).
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.
Lactalis
Industry
Acronym: DELISA
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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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