Cow's Milk Protein AllergyDELISANCT06273371
Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain
An observational study of Cow's Milk Protein Allergy, run by Lactalis at 8 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Cow's Milk Protein Allergy
- What is being tested?
- Damira 2000 Infant formula
- How many people
- 61 participants
- Where
- 8 sitesSpain
- Study dates
- 12 Dec 2023to 21 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- Child
Study population: Infants aged from 0 to 12 months with cow's milk protein allergy
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital Quirónsalud de Córdoba
Córdoba, Andalusia
Clínica privada Dr. Romera
Madrid
Fundación Jiménez Día
Madrid
Hospital Materno infantil de Ourense
Ourense, Galicia
H. Clínico de Santiago
Santiago de Compostela, Galicia
H. Virgen del Rocío
Seville, Andalusia
H. Virgen Macarena
Seville, Andalusia
Instituto Hispalense de pediatría
Seville, Andalusia
About this study
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.
- Conditions
- Cow's Milk Protein Allergy
- Being tested
- Damira 2000 Infant formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damira 2000 Infant formulaOther
100% extensive casein hydrolysate Infant formula
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 : V0 First visit to the hospital
Secondary outcomes (4)
Weight
To evaluate the effect of Damira 2000 on growth outcomes using weight and the related Z-scores weight-for-age (WAZ)
Measured: V1, V2 (4 months)
Height
To evaluate the effect of Damira 2000 on growth outcomes using height and the related Z-scores height-for-age (HAZ).
Measured: V1, V2 (4 months)
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).
Measured: V1, V2, (4 months)
Head circumference
To evaluate the effect of Damira 2000 on growth outcomes using Head circumference and the related Z-Score Head circumference for age.
Measured: V1, V2 (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start12 Dec 2023
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk Protein AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lactalis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273371
- Sponsor's protocol ID
- DELISA2023
- Acronym
- DELISA
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06273371
- Acronym / sponsor ID
- DELISA / DELISA2023
- Conditions
- Cow's Milk Protein Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- LactalisIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Age groups
- Child
- Study population
- Infants aged from 0 to 12 months with cow's milk protein allergy
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Damira 2000 Infant formula100% extensive casein hydrolysate Infant formula | Other | – |
Primary outcome
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.
4 secondary outcomes
Weight
Time frame: V1, V2 (4 months)
Height
Time frame: V1, V2 (4 months)
Weight for height and BMI
Time frame: V1, V2, (4 months)
Head circumference
Time frame: V1, V2 (4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Protein Allergy, run by Lactalis at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance (time frame: Day 0 : V0 First visit to the hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.