IgE-mediated Milk AllergyNCT03466931
Efficacy of the "Milk Ladder" Intervention in the Development of Tolerance and the Recognition of B Cell Epitopes in Babies Who Are Allergic to Cow's Milk Proteins
A study testing Milk in people with IgE-mediated Milk Allergy, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Food allergies have become a relevant health problem in westernized societies, particularly, with children. Cow's milk (CM), along with hen's eggs, are the most common foods eliciting allergic reactions in children under 4 years of age. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- IgE-mediated Milk Allergy
- What is being tested?
- Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to 30 Aug 2021
- Phase
- Interventional
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies of both sexes.
- Age < 12 months.
- Clinical history of immediate reaction (<2 hours) after the intake of baby's formula and/or foods containing cow's milk.
- Sensitization to cow's milk proteins demonstrated by:
- sIgE to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein >0.1KU/l (ImmunoCAP®, ThemoFisher) and/or
- Skin prick test to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein ≥3mm
- If the reaction to milk occurred over 3 months before the recruitment, it will be mandatory to confirm reactivity to milk with an oral food test.
- Parents / legal representatives of the participant voluntary accept to participate.
Who cannot join
- Delayed reactions (> 2 h) after milk intake.
- Contact urticaria to milk if ingestion is well tolerated.
- Previous participation in oral tolerance induction/desensitization protocols.
- Treatment with any medication that might interfere the evaluation of the primary outcome or any study procedure.
- Any disease or condition which presents a contraindication to perform an oral challenge, either open or double-blind or any other study procedure.
- Social circumstances that might interfere with protocol adherence.
- Egg and/or wheat allergy (this exclusion criterion shall be verified before the beginning of the intervention).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Inmuculada Cerecedo, MD, PhD, + 34 91 330 30 00 ext. 7454, inmaculada.cerecedo@salud.madrid.org
About this study
Food allergies have become a relevant health problem in westernized societies, particularly, with children. Cow's milk (CM), along with hen's eggs, are the most common foods eliciting allergic reactions in children under 4 years of age. The main objective of this intervention study is to evaluate the safety and efficacy of the intervention known as "The Milk Ladder" in the development of tolerance by children with CM allergies. This will be compared to an historical cohort (CoALE), which investigated the natural history of this allergy. Additionally, the ability of informative epitopes will be evaluated for their potential to predict tolerance and their correlation against clinical variables.
The "Milk Ladder" will be evaluated within a prospective cohort of CM allergic children. This intervention is enacted through the introduction of meals cooked with progressively increasing amounts of cow's milk into the participant's diet. The primary outcome will be the development of tolerance which will be evaluated through a double-blind placebo-controlled food challenge. IgE and IgG4 epitopes will be described using a peptide microarray immunoassay. Quality of life will be determined by administering the FAQLQ-PF disease-specific questionnaire. Finally, within a subgroup of study participants, the ability of different peptides to activate basophils will be analyzed, and CM T cell epitopes will be studied by means of T-cell proliferation and cytokine production assays.
- Conditions
- IgE-mediated Milk Allergy
- Being tested
- Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkOther
Meals containing Milk and Milk
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | Meals containing Milk and Milk Receives: Other: Milk |
| Historical cohort | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that develop tolerance to milk after the 'Milk Ladder' intervention
Tolerance assessment: participants who successfully pass a double-blind placebo-controlled oral food challenge without experiencing any limiting symptom
Measured: 12 months
Number of participants experiencing any adverse reaction
Number of participants experiencing any adverse reaction to milk-containing foods along the intervention assessed by Medical Dictionary for Regulatory Activities (MedDRA), version in place at the end of the study.
Measured: 12 months
Change in antigen-specific IgE and IgG4 epitopes repertoire
Serum specific inmunnoglobulin levels using a milk peptide microarray immunoassay
Measured: 6 and 18 months
Secondary outcomes (3)
Quality of life
Change in quality of life total score during the intervention, assessed by the disease-specific questionnaire 'Food Allergy Quality of Life Questionnaire - Parent Form'
Measured: 6 and 18 months
Potential T-cell epitopes
Identification of potential T-cell epitopes in serum assessed by a T lymphocyte proliferation assay and cytokine secretion
Measured: 12 months
Ability of the milk allergenic peptides to activate basophils
In vitro determination of basophil activation upon antigen stimulation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Jun 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgE-mediated Milk 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inmaculada Cerecedo, Hospital San Carlos, Madrid
- Investigators
- Inmaculada Cerecedo, e: MD, PhD, Study chair, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466931
- Sponsor's protocol ID
- Milk Ladder
- Status last verified
- Jun 2020
- First submitted
- 2 Feb 2018
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the "Milk Ladder" Intervention in the Development of Tolerance and the Recognition of B Cell Epitopes in Babies Who Are Allergic to Cow's Milk Proteins
- ClinicalTrials.gov ID
- NCT03466931
- Acronym / sponsor ID
- Milk Ladder
- Conditions
- IgE-mediated Milk Allergy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 15 Mar 2018 (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.
Food allergies have become a relevant health problem in westernized societies, particularly, with children. Cow's milk (CM), along with hen's eggs, are the most common foods eliciting allergic reactions in children under 4 years of age. The main objective of this intervention study is to evaluate the safety and efficacy of the intervention known as "The Milk Ladder" in the development of tolerance by children with CM allergies. This will be compared to an historical cohort (CoALE), which investigated the natural history of this allergy. Additionally, the ability of informative epitopes will be evaluated for their potential to predict tolerance and their correlation against clinical variables.
The "Milk Ladder" will be evaluated within a prospective cohort of CM allergic children. This intervention is enacted through the introduction of meals cooked with progressively increasing amounts of cow's milk into the participant's diet. The primary outcome will be the development of tolerance which will be evaluated through a double-blind placebo-controlled food challenge. IgE and IgG4 epitopes will be described using a peptide microarray immunoassay. Quality of life will be determined by administering the FAQLQ-PF disease-specific questionnaire. Finally, within a subgroup of study participants, the ability of different peptides to activate basophils will be analyzed, and CM T cell epitopes will be studied by means of T-cell proliferation and cytokine production assays.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Other: MilkMeals containing Milk and Milk |
| Historical cohort | No intervention | –Standard care |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Babies of both sexes.
- Age < 12 months.
- Clinical history of immediate reaction (<2 hours) after the intake of baby's formula and/or foods containing cow's milk.
- Sensitization to cow's milk proteins demonstrated by:
- If the reaction to milk occurred over 3 months before the recruitment, it will be mandatory to confirm reactivity to milk with an oral food test.
Key exclusion criteria (7 listed)
- Delayed reactions (> 2 h) after milk intake.
- Contact urticaria to milk if ingestion is well tolerated.
- Previous participation in oral tolerance induction/desensitization protocols.
- Treatment with any medication that might interfere the evaluation of the primary outcome or any study procedure.
- Any disease or condition which presents a contraindication to perform an oral challenge, either open or double-blind or any other study procedure.
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 |
|---|---|---|
| MilkMeals containing Milk and Milk | Other | Dietary intervention |
Primary outcome
Number of participants that develop tolerance to milk after the 'Milk Ladder' intervention
Time frame: 12 months
Tolerance assessment: participants who successfully pass a double-blind placebo-controlled oral food challenge without experiencing any limiting symptom
Number of participants experiencing any adverse reaction
Time frame: 12 months
Number of participants experiencing any adverse reaction to milk-containing foods along the intervention assessed by Medical Dictionary for Regulatory Activities (MedDRA), version in place at the end of the study.
Change in antigen-specific IgE and IgG4 epitopes repertoire
Time frame: 6 and 18 months
Serum specific inmunnoglobulin levels using a milk peptide microarray immunoassay
3 secondary outcomes
Quality of life
Time frame: 6 and 18 months
Potential T-cell epitopes
Time frame: 12 months
Ability of the milk allergenic peptides to activate basophils
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Inmaculada Cerecedo, e: MD, PhD study chair
Hospital Clinico San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk in people with IgE-mediated Milk Allergy, run by Hospital San Carlos, Madrid at 1 site 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inmaculada Cerecedo, MD, PhD (+ 34 913303000 ext. 7454, Inmaculada.cerecedo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that develop tolerance to milk after the 'Milk Ladder' intervention (time frame: 12 months). The study lists 3 primary outcomes in all. 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 26 Jun 2020.