Food Allergy in ChildrenNCT05794568
Evaluate the Efficacy of the OITcontrol Application.
A study of Food Allergy in Children, run by Clinica Universidad de Navarra, Universidad de Navarra at 7 sites in Spain.
Trial summary
The main aim of this study is to evaluate the clinical efficacy of the OITcontrol application in patients undergoing OIT of eggs or milk used during the follow-up of this treatment. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy in Children
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 7 sitesSpain
- Study dates
- 15 Nov 2021to 30 Sep 2023
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The patient must be between 4 and 12 years old at the time of informed consent.
- Patients diagnosed with food allergy to eggs and/or milk (clinical history compatible with IgE-mediated reaction with egg or milk together with positive specific IgE against egg white or milk (>0.35kU/L) and/or skin test by intraepidermal puncture equal to or similar to 3mm for egg white or milk); in case of egg allergy, patients may be allergic to raw or undercooked egg despite their tolerance to well-cooked egg.
- The patient, or their legally authorized representative, has given their consent to participate in the study.
- The patient, or his legally authorized representative, has accepted the OIT treatment after the explanation of its risks and benefits and the requirements for the maintenance phase.
- The patient must, in the opinion of the investigator, be able to meet all the requirements of the study.
- The patient, or their legally authorized representative, who assumes the OIT treatment at home, has a Smartphone with internet access via mobile data and/or Wi-Fi available at home.
- Reaction with the OIT allergen in the controlled oral provocation test (POC) included in the initial phase of treatment.
Who cannot join
- Present any of the OIT exclusion criteria:
- Allergy to cow's milk and/or eggs not mediated by IgE.
- Uncontrolled asthma. In the case of a patient with asthma, this must be controlled before the start of OIT.
- Severe atopic dermatitis.
- Previous diagnosis of eosinophilic esogaphitis.
- Inflammatory bowel disease.
Show all 14Show fewer
- Mastocytosis.
- Immunocompromised patients.
- Disorders and/or treatments in which the use of adrenaline is contraindicated.
- Difficulty understanding the risks and benefits of the procedure, and social and family factors that may compromise long-term maintenance therapy. This includes conflicts between parents or legal representatives that may adversely affect treatment.
- Inability of parents or legal representative to follow instructions, identify reactions, or administer medication (especially auto-injectable adrenaline).
- Previous allergic reaction with the corresponding OIT food within the month prior to the initial visit.
- Treatment with omalizumab or any other immunomodulatory biologic drug within the three months prior to the initial visit.
- Pregnant women, or women of childbearing potential not using a safe means of contraception (abstinence is considered an acceptable method) during the entire study period.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital Severo Ochoa
Leganés, Madrid, 28911
Hospital Gregorio Marañón
Madrid, 28009
Hospital Clínico San Carlos
Madrid, 28010
Hospital Infanta Leonor
Madrid, 28031
Hospital Universitario Ramón y Cajal
Madrid, 28034
Universidad de Navarra
Pamplona, Navarre, 31008
About this study
Official title: Multicenter, Open, Controlled, Randomized Study to Evaluate the Efficacy of the OITcontrol Application in Monitoring Patients in OIT With Food.
The main aim of this study is to evaluate the clinical efficacy of the OITcontrol application in patients undergoing OIT of eggs or milk used during the follow-up of this treatment.
Read the detailed description
- Evaluate the quality of life of patients with respect to their food allergy by analyzing the data from the FAQLQ-CF and/or SFAQoL-PF questionnaires.
- Evaluate the perception of patients on the quality and safety of hospital care through the analysis of the adapted SERVQHOS questionnaire and the "Evolution of the perception of patients on the safety of health services".
- Evaluate patient safety with OITcontrol based on:
- Number of reactions in the hospital,
- Number of reactions outside the hospital,
- Compliance with the information and recommendations by the patient:
- recording shots, ii. reaction log, iii. discordances between the medication used and prescribed after a reaction, iv. avoidance of cofactors.
- Evaluate the consumption of health resources regarding the use, derived from the OIT of the following resources:
- Number of extraordinary visits to the allergy department,
- Number of phone calls for questions,
- Number of visits to the emergency department.
- Conditions
- Food Allergy in Children
- Being tested
- OITcontrol app monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OITcontrol app monitoringDevice
App to monitor OIT patients
| Study group | Role | What they receive |
|---|---|---|
| OITcontrol group | Active comparator | Not described Receives: Device: OITcontrol app monitoring |
| paperPRO group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of OITcontrol as an application to improve the quality of life.
Improve the quality of life of patients, as well as their perception of the quality and safety of hospital care, safety and the reduction of the consumption of health resources in patients under OITcontrol.
- Baseline variables of the patient's clinical history in relation to their allergy to the allergen in the OIT, their base treatment and/or premedication, and the baseline sensitization parameters (skin test, total and specific IgE to the allergen of the OIT) obtained in the V0. The variables of the first day of treatment will be collected: threshold dose, last tolerated dose, and type of reaction presented.
- The variables in the escalation visits will be taken in the space of time between two hospital visits. The data to be collected in a hospital visit correspond to the events that occurred during that hospital visit and in the home doses or extraordinary hospital visits of the previous week from the last ordinary hospi
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start15 Nov 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794568
- Sponsor's protocol ID
- OITcontrol_QL
- Status last verified
- Nov 2022
- First submitted
- 20 Mar 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open, Controlled, Randomized Study to Evaluate the Efficacy of the OITcontrol Application in Monitoring Patients in OIT With Food.
- ClinicalTrials.gov ID
- NCT05794568
- Acronym / sponsor ID
- OITcontrol_QL
- Conditions
- Food Allergy in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 3 Apr 2023 (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.
The main aim of this study is to evaluate the clinical efficacy of the OITcontrol application in patients undergoing OIT of eggs or milk used during the follow-up of this treatment.
Detailed description
- Evaluate the quality of life of patients with respect to their food allergy by analyzing the data from the FAQLQ-CF and/or SFAQoL-PF questionnaires.
- Evaluate the perception of patients on the quality and safety of hospital care through the analysis of the adapted SERVQHOS questionnaire and the "Evolution of the perception of patients on the safety of health services".
- Evaluate patient safety with OITcontrol based on:
- Number of reactions in the hospital,
- Number of reactions outside the hospital,
- Compliance with the information and recommendations by the patient:
- recording shots, ii. reaction log, iii. discordances between the medication used and prescribed after a reaction, iv. avoidance of cofactors.
- Evaluate the consumption of health resources regarding the use, derived from the OIT of the following resources:
- Number of extraordinary visits to the allergy department,
- Number of phone calls for questions,
- Number of visits to the emergency department.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OITcontrol group | Active comparator | Device: OITcontrol app monitoring |
| paperPRO group | No intervention | – |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The patient must be between 4 and 12 years old at the time of informed consent.
- Patients diagnosed with food allergy to eggs and/or milk (clinical history compatible with IgE-mediated reaction with egg or milk together with positive specific IgE against egg white or milk (>0.35kU/L) and/or skin test by intraepidermal puncture equal to or similar to 3mm for egg white or milk); in case of egg allergy, patients may be allergic to raw or undercooked egg despite their tolerance to well-cooked egg.
- The patient, or their legally authorized representative, has given their consent to participate in the study.
- The patient, or his legally authorized representative, has accepted the OIT treatment after the explanation of its risks and benefits and the requirements for the maintenance phase.
- The patient must, in the opinion of the investigator, be able to meet all the requirements of the study.
Key exclusion criteria (14 listed)
- Present any of the OIT exclusion criteria:
- Previous allergic reaction with the corresponding OIT food within the month prior to the initial visit.
- Treatment with omalizumab or any other immunomodulatory biologic drug within the three months prior to the initial visit.
- Pregnant women, or women of childbearing potential not using a safe means of contraception (abstinence is considered an acceptable method) during the entire study period.
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 |
|---|---|---|
| OITcontrol app monitoringApp to monitor OIT patients | Device | OITcontrol group |
Primary outcome
The effectiveness of OITcontrol as an application to improve the quality of life.
Time frame: 12 weeks
Improve the quality of life of patients, as well as their perception of the quality and safety of hospital care, safety and the reduction of the consumption of health resources in patients under OITcontrol. * Baseline variables of the patient's clinical history in relation to their allergy to the allergen in the OIT, their base treatment and/or premedication, and the baseline sensitization parameters (skin test, total and specific IgE to the allergen of the OIT) obtained in the V0. The variables of the first day of treatment will be collected: threshold dose, last tolerated dose, and type of reaction presented. * The variables in the escalation visits will be taken in the space of time between two hospital visits. The data to be collected in a hospital visit correspond to the events that occurred during that hospital visit and in the home doses or extraordinary hospital visits of the previous week from the last ordinary hospi
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 10 Oct 2023.
Related trials for Food Allergy in Children
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
Not yet recruiting
Oral Immunotherapy for Children With Egg Allergy
Egg Allergy, Egg Hypersensitivity
Not yet recruitingPhase 2
UNC Cashew Sublingual Immunotherapy
Cashew Nut Allergy, Tree Nut Allergies
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
Not yet recruiting
Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew Allergy
Food Allergy in Children
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Food Allergy in Children, run by Clinica Universidad de Navarra, Universidad de Navarra at 7 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 7 inclusion and 14 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The effectiveness of OITcontrol as an application to improve the quality of life. (time frame: 12 weeks). 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 10 Oct 2023.