Food HypersensitivityEarly Phase 1NCT00578656
An Interventional Study of Milk Allergy
A Early Phase 1 study testing Baked Milk in people with Food Hypersensitivity and Milk Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Milk is the among the most common food allergens in infants and children. The majority of children outgrow their allergies; however, the exact mechanisms by which food tolerance is achieved are unknown. Strict avoidance of the offending food is currently the only known therapy. Read more about this study
- Who is it for?
- Ages 4 to 25 years
- Conditions the study is for
- Food Hypersensitivity, Milk Hypersensitivity
- What is being tested?
- Baked Milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Feb 2011
- Phase
- Early Phase 1
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Positive prick skin test to milk and/or detectable serum milk-IgE
- History of allergic reaction to milk within past 6 months
- Serum milk-IgE of high predictive value (>15 in children older than 1 year, >5 in children younger than 1 year)
- Asymptomatic or stabilized atopic disease (asthma, allergic rhinitis, atopic dermatitis) for a minimum of 7 days prior to OFC
Who cannot join
- Serum level of cow's milk-specific IgE antibody greater than 35 kIU/L
- History of anaphylactic reaction to cow's milk within the past 12 months
- Unstable asthma
- Allergic eosinophilic gastroenteritis caused by milk
- Use of short-acting antihistamines more than one time within 3 days of OFC
- Use of medium-acting antihistamines more than one time within 7 days of OFC
Show all 9Show fewer
- Maintenance therapy or use of beta-blockers and ACE inhibitors within 12 to 24 hours of OFC
- Participation in study baked egg study GCO#03-0609 within 6 months of enrollment
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of the Diet Containing Limited Amounts of Processed Milk Protein on the Natural History of IgE-Mediated Milk Hypersensitivity
Milk is the among the most common food allergens in infants and children. The majority of children outgrow their allergies; however, the exact mechanisms by which food tolerance is achieved are unknown. Strict avoidance of the offending food is currently the only known therapy. However, subjects have been known to lose food hypersensitivity while frequently ingesting small amounts of processed forms of the offending product. The purpose of this study is to investigate whether ingestion of small amounts of processed milk protein will be permitted without compromising the chances of either outgrowing milk hypersensitivity or prolonging the time needed to achieve clinical tolerance.
Read the detailed description
In the United States, as many as 6% of children are affected by food allergy. Milk is among the most common food allergens in infants and children. Although strict avoidance of milk is the current standard of care for those with milk hypersensitivity, there is no conclusive evidence that absolute dietary restriction is necessary for achieving clinical tolerance. The purpose of this study is to determine whether ingestion of small amounts of extensively heated milk protein might be permitted without compromising the chances for ultimately losing milk hypersensitivity or prolonging the time needed to achieve clinical tolerance in a selected population of milk-allergic participants.
The study will last up to 48 months. Based on the result of the oral food challenge with baked milk the participants will be assigned to either Group 1 (baked milk-tolerant) or Group 2 (baked milk-reactive). Participants in the Group 1 may be further tested with regular, non-heated milk, depending on their diagnostic test results and clinical history. Participants tolerant to non-heated milk will be discharged from the study. Baked milk-tolerant, non-heated milk-reactive participants in Group 1 will receive diet with baked milk at home while Group 2 will act as the control and avoid milk consumption strictly.
Qualifying and willing participants will be assigned to Group 1, which will allow consumption of baked milk on a regular basis. Study visits will occur at Months 3, 6, 12, 18, 24, 30, 36, 42, and 48. Participants in Group 1 will be given an OFC using non-heated milk to identify tolerant individuals at Months 12, 24, 36, and 48.
Participants in Group 2 will be contacted by telephone every 6 months and asked about the current state of their milk allergy. Participants in this group will be asked to repeat OFC to baked milk at Months 12, 24, 36, and 48. Depending on the outcome of the repeat OFC, they may continue strict avoidance (if they reacted during baked milk OFC) or will be allowed to ingest baked milk in the diet (if they tolerated baked milk OFC).
At each visit, medical history, physical exam, 7-day diet record, anthropometric measurements, skin test and blood collection will occur. A pregnancy test will be performed at all visits requiring OFC for females of childbearing potential. A skin prick test will occur at most visits. Participants with atopic dermatitis will be assessed on the SCORAD scale at all visits.
- Conditions
- Food Hypersensitivity, Milk Hypersensitivity
- Being tested
- Baked Milk
- Keywords
- Food Allergy, Milk Allergy
- Medical subject headings
- Food Hypersensitivity, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baked MilkDietary supplement
Extensively heated milk
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Baked milk and at least 4 oral food challenges as clinically indicated Receives: Dietary Supplement: Baked Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance to heated milk
Measured: Throughout study
Secondary outcomes (1)
Development of tolerance to non-heated milk
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startJun 2004
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hugh A. Sampson, MD, Principal investigatorScott H. Sicherer, MD, Principal investigatorAnna Nowak-Wegrzyn, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578656
- Sponsor's protocol ID
- DAIT P01 AI 144236
- Other IDs
- GCO#01-1209
- Status last verified
- Jul 2012
- First submitted
- 19 Dec 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
Publications
Skripak JM, Matsui EC, Mudd K, Wood RA. The natural history of IgE-mediated cow's milk allergy. J Allergy Clin Immunol. 2007 Nov;120(5):1172-7. doi: 10.1016/j.jaci.2007.08.023. Epub 2007 Nov 1.
PubMed 17935766Staden U, Rolinck-Werninghaus C, Brewe F, Wahn U, Niggemann B, Beyer K. Specific oral tolerance induction in food allergy in children: efficacy and clinical patterns of reaction. Allergy. 2007 Nov;62(11):1261-9. doi: 10.1111/j.1398-9995.2007.01501.x.
PubMed 17919140Vandenplas Y, Koletzko S, Isolauri E, Hill D, Oranje AP, Brueton M, Staiano A, Dupont C. Guidelines for the diagnosis and management of cow's milk protein allergy in infants. Arch Dis Child. 2007 Oct;92(10):902-8. doi: 10.1136/adc.2006.110999.
PubMed 17895338
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Diet Containing Limited Amounts of Processed Milk Protein on the Natural History of IgE-Mediated Milk Hypersensitivity
- ClinicalTrials.gov ID
- NCT00578656
- Acronym / sponsor ID
- DAIT P01 AI 144236
- Conditions
- Food Hypersensitivity, Milk Hypersensitivity
- Keywords
- Food Allergy, Milk Allergy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2004
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Dec 2007 (estimated)
- 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.
Milk is the among the most common food allergens in infants and children. The majority of children outgrow their allergies; however, the exact mechanisms by which food tolerance is achieved are unknown. Strict avoidance of the offending food is currently the only known therapy. However, subjects have been known to lose food hypersensitivity while frequently ingesting small amounts of processed forms of the offending product. The purpose of this study is to investigate whether ingestion of small amounts of processed milk protein will be permitted without compromising the chances of either outgrowing milk hypersensitivity or prolonging the time needed to achieve clinical tolerance.
Detailed description
In the United States, as many as 6% of children are affected by food allergy. Milk is among the most common food allergens in infants and children. Although strict avoidance of milk is the current standard of care for those with milk hypersensitivity, there is no conclusive evidence that absolute dietary restriction is necessary for achieving clinical tolerance. The purpose of this study is to determine whether ingestion of small amounts of extensively heated milk protein might be permitted without compromising the chances for ultimately losing milk hypersensitivity or prolonging the time needed to achieve clinical tolerance in a selected population of milk-allergic participants.
The study will last up to 48 months. Based on the result of the oral food challenge with baked milk the participants will be assigned to either Group 1 (baked milk-tolerant) or Group 2 (baked milk-reactive). Participants in the Group 1 may be further tested with regular, non-heated milk, depending on their diagnostic test results and clinical history. Participants tolerant to non-heated milk will be discharged from the study. Baked milk-tolerant, non-heated milk-reactive participants in Group 1 will receive diet with baked milk at home while Group 2 will act as the control and avoid milk consumption strictly.
Qualifying and willing participants will be assigned to Group 1, which will allow consumption of baked milk on a regular basis. Study visits will occur at Months 3, 6, 12, 18, 24, 30, 36, 42, and 48. Participants in Group 1 will be given an OFC using non-heated milk to identify tolerant individuals at Months 12, 24, 36, and 48.
Participants in Group 2 will be contacted by telephone every 6 months and asked about the current state of their milk allergy. Participants in this group will be asked to repeat OFC to baked milk at Months 12, 24, 36, and 48. Depending on the outcome of the repeat OFC, they may continue strict avoidance (if they reacted during baked milk OFC) or will be allowed to ingest baked milk in the diet (if they tolerated baked milk OFC).
At each visit, medical history, physical exam, 7-day diet record, anthropometric measurements, skin test and blood collection will occur. A pregnancy test will be performed at all visits requiring OFC for females of childbearing potential. A skin prick test will occur at most visits. Participants with atopic dermatitis will be assessed on the SCORAD scale at all visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Baked MilkBaked milk and at least 4 oral food challenges as clinically indicated |
Who may qualify
- Ages
- 4 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Positive prick skin test to milk and/or detectable serum milk-IgE
- History of allergic reaction to milk within past 6 months
- Serum milk-IgE of high predictive value (>15 in children older than 1 year, >5 in children younger than 1 year)
- Asymptomatic or stabilized atopic disease (asthma, allergic rhinitis, atopic dermatitis) for a minimum of 7 days prior to OFC
Key exclusion criteria (9 listed)
- Serum level of cow's milk-specific IgE antibody greater than 35 kIU/L
- History of anaphylactic reaction to cow's milk within the past 12 months
- Unstable asthma
- Allergic eosinophilic gastroenteritis caused by milk
- Use of short-acting antihistamines more than one time within 3 days of OFC
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 |
|---|---|---|
| Baked MilkExtensively heated milk | Dietary supplement | 1 |
Primary outcome
Tolerance to heated milk
Time frame: Throughout study
1 secondary outcome
Development of tolerance to non-heated milk
Time frame: Throughout study
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 1 Aug 2012.
- Background: PubMed 17935766Skripak JM, Matsui EC, Mudd K, Wood RA. The natural history of IgE-mediated cow's milk allergy. J Allergy Clin Immunol. 2007 Nov;120(5):1172-7. doi: 10.1016/j.jaci.2007.08.023. Epub 2007 Nov 1.
- Background: PubMed 17919140Staden U, Rolinck-Werninghaus C, Brewe F, Wahn U, Niggemann B, Beyer K. Specific oral tolerance induction in food allergy in children: efficacy and clinical patterns of reaction. Allergy. 2007 Nov;62(11):1261-9. doi: 10.1111/j.1398-9995.2007.01501.x.
- Background: PubMed 17895338Vandenplas Y, Koletzko S, Isolauri E, Hill D, Oranje AP, Brueton M, Staiano A, Dupont C. Guidelines for the diagnosis and management of cow's milk protein allergy in infants. Arch Dis Child. 2007 Oct;92(10):902-8. doi: 10.1136/adc.2006.110999.
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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.
Hugh A. Sampson, MD principal investigator
Scott H. Sicherer, MD principal investigator
Anna Nowak-Wegrzyn, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Baked Milk in people with Food Hypersensitivity and Milk Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 4 inclusion and 9 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 1 Aug 2012. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Tolerance to heated milk (time frame: Throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00578656, which also lists 3 linked publications.
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 1 Aug 2012.