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Baked Milk Oral Immunotherapy for Cow's Milk Allergy

Study Purpose

The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.

Recruitment Criteria

Accepts Healthy Volunteers

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

No
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 3 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who: - Are age 3-18 years, either sex, any ethnicity or race - Provide signed informed consent by parent or legal guardian and informed assent if applicable - Have a history of symptomatic reactivity to cow's milk (i.e. eczema, urticarial, upper or lower respiratory symptoms, gastrointestinal disturbances, rash, oral symptoms) - Have a skin prick test positive to milk (diameter of wheal 3 mm ≥ negative control) and serum milk-specific immunoglobulin E (IgE) level >5 kiloUnits (kU)/L within the past 6-12 months - Have a positive reaction to a cumulative dose of ≤444 mg of baked milk powder in the initial qualifying double blind placebo-controlled food challenge.
  • - Use an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
  • - Have self-injectable epinephrine available at all times

    Exclusion Criteria:

    - Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who: - Have a history of severe anaphylaxis resulting in hypotension, neurological compromise, or mechanical ventilation - Have a history of intubation related to asthma - Tolerate more than 444 mg of baked milk powder at the initial qualifying double blind placebo controlled food challenge.
  • - Allergy to placebo ingredients or reacts to any dose of placebo during the qualifying oral food challenge.
  • - Poor control of atopic dermatitis - Are unable to tolerate at least 3 mg of baked milk protein on dose escalation day - Are pregnant or lactating - Have severe asthma defined by 2007 National Heart Lung and Blood Institute (NHLBI) Criteria Steps 5 or 6 - Have severe or poorly controlled asthma defined by with any of the following criteria: 1.
Forced expiratory volume in 1 second (FEV1) <80% of predicted 2. Inhaled corticosteroid dosing dosing of >500 mcg daily of fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart) or 3. ≥ 1 hospitalization in the past year for asthma or 4. > 1 emergency department visit in the past 6 months for asthma
  • - Use of steroid medications (oral steroids, such as prednisone or Medrol, steroid injections, such as Kenalog, or intravenous or oral corticosteroid burst) in the following manners: History of daily oral steroid dosing within 4 weeks prior to baseline visit or for > 1 month during the past year or >2 burst oral steroid courses in the past 6 months.
  • - Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges - Are receiving omalizumab, mepolizumab, beta- blocker, angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin-receptor blockers, calcium channel blockers, or tricyclic antidepressant therapy - Have used immunomodulatory therapy (not including corticosteroids) or biologic therapy within the past year - Have participated in any interventional study for treatment of a food allergy in the past 6 months - Are on 'build up phase' of environmental allergen immunotherapy.
Subjects tolerating maintenance allergen immunotherapy can be enrolled. - Have a history of eosinophilic esophagitis in the past 3 years - Have a chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes) - Have used an investigational drug within 90 days or plan to use an investigational drug during the study period - Severe reaction at initial double blind placebo controlled food challenge, defined as: - Life-threatening anaphylaxis - Requiring overnight hospitalization

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.

NCT03462030
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.

Phase 1
Lead Sponsor

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

Johns Hopkins University
Principal Investigator

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

Robert Wood, MD
Principal Investigator Affiliation Johns Hopkins University
Agency Class

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

OtherOtherOther
Overall Status Active, not recruiting
Countries United States
Conditions

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

Cow's Milk Allergy
Additional Details

This study is designed to assess the safety of baked milk oral immunotherapy among patients who are milk allergic and who do not pass a baked milk challenge.

Arms & Interventions

Arms

Experimental: Baked Milk Immunotherapy

Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.

Placebo Comparator: Placebo

Subjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.

Interventions

Drug: - Baked non-fat cow's milk powder

Oral immunotherapy with increasing quantities of baked milk.

Drug: - Placebo: Tapioca Powder

Placebo control.

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.

Johns Hopkins Hospital, Baltimore, Maryland

Status

Address

Johns Hopkins Hospital

Baltimore, Maryland, 21287

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