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Evaluate the Efficacy of the OITcontrol Application.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 4 Years - 12 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - Present any of the OIT

    exclusion criteria:

    1.
Allergy to cow's milk and/or eggs not mediated by IgE. 2. Uncontrolled asthma. In the case of a patient with asthma, this must be controlled before the start of OIT. 3. Severe atopic dermatitis. 4. Previous diagnosis of eosinophilic esogaphitis. 5. Inflammatory bowel disease. 6. Mastocytosis. 7. Immunocompromised patients. 8. Disorders and/or treatments in which the use of adrenaline is contraindicated. 9. 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. 10. 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05794568
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Clinica Universidad de Navarra, Universidad de Navarra
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy in Children
Additional Details

1. 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. 2. 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". 3. Evaluate patient safety with OITcontrol based on: 1. Number of reactions in the hospital, 2. Number of reactions outside the hospital, 3. Compliance with the information and recommendations by the patient: i. recording shots, ii. reaction log, iii. discordances between the medication used and prescribed after a reaction, iv. avoidance of cofactors. 4. Evaluate the consumption of health resources regarding the use, derived from the OIT of the following resources: 1. Number of extraordinary visits to the allergy department, 2. Number of phone calls for questions, 3. Number of visits to the emergency department.

Arms & Interventions

Arms

Active Comparator: OITcontrol group

No Intervention: paperPRO group

Interventions

Device: - OITcontrol app monitoring

App to monitor OIT patients

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Clínico San Carlos, Madrid, Spain

Status

Recruiting

Address

Hospital Clínico San Carlos

Madrid, , 28010

Site Contact

Sonia Vázquez Cortés

[email protected]

651143974

Hospital Infanta Leonor, Madrid, Spain

Status

Recruiting

Address

Hospital Infanta Leonor

Madrid, , 28031

Site Contact

Francisco Javier Ruano

[email protected]

651143974

Hospital Universitario Ramón y Cajal, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramón y Cajal

Madrid, , 28034

Site Contact

María Soledad Terrados

[email protected]

651143974

Hospital Fundación Alcorcón, Alcorcón, Madrid, Spain

Status

Recruiting

Address

Hospital Fundación Alcorcón

Alcorcón, Madrid, 28922

Site Contact

María Dolores Alonso Díaz de Durana

[email protected]

651143974

Hospital Severo Ochoa, Leganés, Madrid, Spain

Status

Recruiting

Address

Hospital Severo Ochoa

Leganés, Madrid, 28911

Site Contact

Sergio José Quevedo

[email protected]

651143974

Universidad de Navarra, Pamplona, Navarra, Spain

Status

Active, not recruiting

Address

Universidad de Navarra

Pamplona, Navarra, 31008

Hospital Gregorio Marañón, Madrid, Spain

Status

Recruiting

Address

Hospital Gregorio Marañón

Madrid, , 28009

Site Contact

Paula Cabrera Freitag

[email protected]

651143974

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