A Phase 2 interventional study of Baked non-fat cow's milk powder and Placebo: Tapioca Powder in Cow's Milk Allergy, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.
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.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's enrollment of 41 is below the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:
Exclusion Criteria:
Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:
Have severe or poorly controlled asthma defined by with any of the following criteria:
Severe reaction at initial double blind placebo controlled food challenge, defined as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Baked non-fat cow's milk powder
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.
Drug: Placebo: Tapioca Powder
Oral immunotherapy with increasing quantities of baked milk.
Also known as: Investigational New Drug (IND) 17114
Placebo control.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Adverse events will be recorded per CTCAE version 4.0. Events per dose on baked milk oral immunotherapy will be compared to adverse events per dose on placebo. Data will be collected over the first year of treatment. Analysis of cumulative adverse reactions per dose of oral immunotherapy or placebo will be performed at the end of year 1.
Time frame: 1 year
Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment
The investigators will perform baked milk challenges to 4044 mg of baked milk protein and calculate the proportion of subjects who tolerate 4 grams of baked milk protein after one year of baked milk oral immunotherapy. This measure reports the number of participants that were able to tolerate 4 grams of baked milk protein.
Time frame: 1 year
Number of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment
The investigators will perform unheated milk challenges to up to 8000 mg of unheated milk protein and calculate the proportion of subjects who tolerate 2 grams of unheated milk protein after 2 years of treatment. This measure reports the number of participants that were able to tolerate 2 grams of unheated milk protein.
Time frame: 2 years
Change in Maximum Tolerated Dose of Baked Milk
Change in maximum tolerated dose (milligrams) of baked milk from baseline to end of year 1 and end of year 2.
Time frame: Baseline, 1 year and 2 years
Change in Milk-specific IgE Level
Change in milk-specific immunoglobulin E (IgE) level measured in kU/L.
Time frame: Baseline and up to year 2
Change in Milk-specific IgG4 Level
Change in milk-specific immunoglobulin G4 (IgG4) level measured in mg/L.
Time frame: Baseline and up to year 2
Change in Milk Skin Prick Test Responses
Change in milk skin prick test responses measured as a change in wheal size in millimeters.
Time frame: Baseline and up to year 2
Change in Quality of Life as Assessed by the Food Allergy Questionnaire
The food allergy questionnaire has an overall score range of 0-6 with 6 indicating the worst quality of life.
Time frame: Baseline and up to year 2
Participants were recruited from the Johns Hopkins (JH) Pediatric Allergy Clinic, Baltimore, MD from March 2018 to October 2019.
| Milestone | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| Started | 15 | 15 |
| End of build-up | 14 | 14 |
| Month 12 food challenge | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
Adverse events will be recorded per CTCAE version 4.0. Events per dose on baked milk oral immunotherapy will be compared to adverse events per dose on placebo. Data will be collected over the first year of treatment. Analysis of cumulative adverse reactions per dose of oral immunotherapy or placebo will be performed at the end of year 1.
| Participants | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 15 | 11 |
The investigators will perform baked milk challenges to 4044 mg of baked milk protein and calculate the proportion of subjects who tolerate 4 grams of baked milk protein after one year of baked milk oral immunotherapy. This measure reports the number of participants that were able to tolerate 4 grams of baked milk protein.
| Participants | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment | 11 | 0 |
The investigators will perform unheated milk challenges to up to 8000 mg of unheated milk protein and calculate the proportion of subjects who tolerate 2 grams of unheated milk protein after 2 years of treatment. This measure reports the number of participants that were able to tolerate 2 grams of unheated milk protein.
| Participants | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| Number of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment | 8 | 5 |
Change in maximum tolerated dose (milligrams) of baked milk from baseline to end of year 1 and end of year 2.
| miligrams | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| Change from baseline to 1 year | 3900 (2256 to 4025) | 0 (0 to 757) |
| Change from baseline to 2 years | 3900 (2371 to 4025) | 3900 (2031 to 3900) |
Change in milk-specific immunoglobulin E (IgE) level measured in kU/L.
| KU/L | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| change from baseline to 1 year | -21.35 (-40.08 to 6.67) | -14.75 (-41.73 to 12.42) |
| change from baseline to 2 years | -77.45 (-138.95 to -15.69) | -46.65 (-109.47 to -14.60) |
Change in milk-specific immunoglobulin G4 (IgG4) level measured in mg/L.
| mg/L | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| change from baseline to 1 year | 8.88 (4.58 to 85.34) | 3.79 (2.69 to 4.26) |
| Change from baseline to 2 years | 5.5 (1.79 to 8.99) | 3.55 (2.45 to 11.26) |
Change in milk skin prick test responses measured as a change in wheal size in millimeters.
| millimeters | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| Change from baseline to year 1 | -2.5 (-10 to 3) | 3.5 (-2.16 to 14.99) |
| Change from baseline to 2 years | -4 (-7.79 to 1.79) | 1.5 (-6.47 to 10) |
The food allergy questionnaire has an overall score range of 0-6 with 6 indicating the worst quality of life.
| score on a scale | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| change from baseline to 1 year | 0.04 ± 0.79 | 0.37 ± 1.08 |
| change from baseline to 2 years | -0.07 ± 0.94 | -0.3 ± 1.16 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baked Milk Immunotherapy | 0/15 (0%) | 0/15 (0%) | 15/15 (100%) |
| Placebo | 0/15 (0%) | 3/15 (20%) | 14/15 (93.3%) |
| Event | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| Hospitalization - asthmaRespiratory, thoracic and mediastinal disorders | 0/15 | 2/15 |
| Hospitalization - mental healthPsychiatric disorders | 0/15 | 1/15 |
| Event | Baked Milk Immunotherapy | Placebo |
|---|---|---|
| Gastrointestinal symptomsGastrointestinal disorders | 15/15 | 14/15 |
| Oropharyngeal symptomsGeneral disorders | 14/15 | 8/15 |
| Cutaneous symptomsSkin and subcutaneous tissue disorders | 14/15 | 12/15 |
| Lower respiratory tract symptomsRespiratory, thoracic and mediastinal disorders | 12/15 | 14/15 |
| Age, Categorical(Participants) | Baked Milk Immunotherapy | Placebo | Total |
|---|---|---|---|
| <=18 years | 12 | 15 | 27 |
| Between 18 and 65 years | 3 | 0 | 3 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Baked Milk Immunotherapy | Placebo | Total |
|---|---|---|---|
| Median | 13 (4 to 18) | 7 (3 to 14) | 11 (3 to 18) |
| Sex: Female, Male(Participants) | Baked Milk Immunotherapy | Placebo | Total |
|---|---|---|---|
| Female | 8 | 6 | 14 |
| Male | 7 | 9 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Baked Milk Immunotherapy | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 15 | 14 | 29 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Baked Milk Immunotherapy | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 12 | 9 | 21 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Baked Milk Immunotherapy | Placebo | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
| Cow's Milk IgE(kU/L) | Baked Milk Immunotherapy | Placebo | Total |
|---|---|---|---|
| Median | 114 (7 to 1625) | 87 (22 to 772) | 88 (7 to 1625) |
| Age at Milk Allergy Diagnosis(months) | Baked Milk Immunotherapy | Placebo | Total |
|---|---|---|---|
| Median | 8 (4 to 14) | 9 (4 to 24) | 8.5 (4 to 24) |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Jan 2021, 34 months.
Results were first posted in Dec 2021, 10 months after primary completion.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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