An Interventional Study of Milk Allergy and Tolerance in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00778258
First received: October 21, 2008
Last updated: October 24, 2013
Last verified: October 2013

October 21, 2008
October 24, 2013
August 2008
August 2015   (final data collection date for primary outcome measure)
Ratio for progression in tolerance of baked milk and ultimately unheated milk in Dose escalation sub-arm compared to Maintenance sub-arm 2 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00778258 on ClinicalTrials.gov Archive Site
  • Odds ratio for progression in tolerating more allergenic forms of milk [ Time Frame: At Months 12 and 24 ] [ Designated as safety issue: No ]
  • Percent of participants becoming tolerant to unheated cow's milk [ Time Frame: At Months 12, 24, and 36 ] [ Designated as safety issue: No ]
  • Percent of participants who develop tolerance to unheated cow's milk [ Time Frame: Through 36 Months ] [ Designated as safety issue: No ]
  • Correlation of baseline mechanistic studies [humoral, T cell and basophil] and stool CD23 and IgE with the outcome of the baseline OFC to identify the biomarkers of clinical reactivity and persistence of milk allergy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Relationship between initial dose of tolerated baked-milk protein and time to complete tolerance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Relationship between reactivity to casein versus whey fractions and time to complete tolerance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Relationship between dose of baked-milk protein and reactivity to casein versus whey and type of symptoms elicited during OFC [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Comparison of percent of participants tolerant to non-heated milk protein between the participants in Arms 1 and 2 [ Time Frame: At Months 12, 24, and 36 ] [ Designated as safety issue: No ]
  • Comparison of percent of participants tolerant to non-heated milk between the participants who ingested baked-milk products and participants who continued to avoid all forms of milk [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Changes in Mechanistic Values [humoral, T cell and basophil] [ Time Frame: 0, 12, 24, and 36 months ] [ Designated as safety issue: No ]
  • Change in Mechanistic Values [humoral, T cell and basophil] [ Time Frame: Baseline to the time complete milk tolerance was established ] [ Designated as safety issue: No ]
  • Odds ratio for progression in tolerating more allergenic forms of milk [ Time Frame: At Months 12 and 24 ] [ Designated as safety issue: No ]
  • Percent of participants becoming tolerant to unheated cow's milk [ Time Frame: At Months 12, 24, and 36 ] [ Designated as safety issue: No ]
  • Percent of participants who develop tolerance to unheated cow's milk [ Time Frame: Through 36 Months ] [ Designated as safety issue: No ]
  • Correlation of baseline mechanistic studies [humoral, T cell and basophil] and stool CD23 and IgE with the outcome of the baseline OFC to identify the biomarkers of clinical reactivity and persistence of milk allergy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Relationship between initial dose of tolerated baked-milk protein and time to complete tolerance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Relationship between reactivity to casein versus whey fractions and time to complete tolerance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Relationship between dose of baked-milk protein and reactivity to casein versus whey and type of symptoms elicited during OFC [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Comparison of percent of participants tolerant to non-heated milk protein between the participants in Arms 1 and 2 [ Time Frame: At Months 12, 24, and 36 ] [ Designated as safety issue: No ]
  • Comparison of percent of participants tolerant to non-heated milk between the participants who ingested baked-milk products and participants who continued to avoid all forms of milk [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Interventional Study of Milk Allergy and Tolerance in Children
Dietary Intervention in Milk Allergy and Tolerance Development

Milk is among the most common food allergens in infants and children. The majority of children outgrow their milk 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, some have been known to tolerate milk products cooked at high heat such as when baked in foods. The purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Food Hypersensitivity
  • Milk Hypersensitivity
  • Biological: Baked Milk
    At baseline, each subject will undergo sequential oral food challenges with the products that contain increasing amounts of milk protein that are baked: Stage 1 (muffin), Stage 2 (pizza), and Stage 3 (rice pudding) doses of baked milk to determine the extent to which they tolerate various baked milk proteins. Based on the outcomes of the baseline oral food challenges, subjects will be assigned to one of the 5 study arms.
  • Biological: Non-baked Milk
    Those subjects tolerant to rice pudding will undergo oral food challenge with non-baked milk.
  • Experimental: Milk-allergic; Non-consumption
    Subjects in this arm reacted to the lowest baseline dose of baked milk (muffin) and will continue strict milk avoidance, returning for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months. Individual participants may be challenged at 12 and or 24 months.
    Intervention: Biological: Baked Milk
  • Experimental: Tolerated Muffin, Reacted to Pizza
    Subjects will be assigned to this arm, if they can tolerate ingesting a muffin but react to ingesting the amount of baked milk in a standardized portion of pizza. Within the arm, subjects will be randomized in 1:1 ratio to either return for re-evaluation at 6 months (Dose Escalation sub-arm) or 12 months (Maintenance sub-arm) to determine whether they might progress to ingesting higher amounts of baked milk protein.
    Intervention: Biological: Baked Milk
  • Experimental: Reacted to Rice Pudding
    Subjects will be assigned to this arm, if they can tolerate ingesting a muffin and a standardized portion of pizza but react to a standardized dose of baked milk in rice pudding. Within the arm, subjects will be randomized in 1:1 ratio to either return for re-evaluation at 6 months (Dose Escalation sub-arm) or 12 months (Maintenance sub-arm) to determine whether they might progress to ingesting higher amounts of baked milk protein.
    Intervention: Biological: Baked Milk
  • Experimental: Reacted to Non-baked Milk
    Subjects will be assigned to this arm, if they can tolerate ingesting a muffin, pizza and rice pudding but react to a standardized dose of non-baked milk. Within the arm, subjects will be randomized in 1:1 ratio to either return for re-evaluation at 6 months (Dose Escalation sub-arm) or 12 months (Maintenance sub-arm) to determine whether they might progress to ingesting higher amounts of baked milk protein.
    Interventions:
    • Biological: Baked Milk
    • Biological: Non-baked Milk
  • Experimental: Tolerant to Baked and Non-baked Milk
    Interventions:
    • Biological: Baked Milk
    • Biological: Non-baked Milk
  • No Intervention: Non-Interventional Comparison
    Thirty subjects who fulfill inclusion criteria but are unwilling to participate in the full protocol will be enrolled as a comparison group to the active arms.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

One or more of the following inclusion criteria for enrollment in the study have to be met:

  1. Convincing history of an allergic reaction to milk or a positive DBPCMC within the past 2 years and either detectable milk IgE or positive prick skin test to milk.

    OR

  2. Serum milk-IgE of high predictive value >14 kUA/L or prick skin test to milk > 10mm wheal within the past 6 months regardless of past clinical history of reactions OR
  3. Convincing history of an allergic reaction to milk or a positive DBPCMC more than 2 years ago and either a positive serum milk-IgE < 14 kUA/L or positive prick skin test to milk < 10 mm wheal within the past 6 months (eligible only for the active arm of the study and will undergo a reversed sequence of initial baked-milk challenges)

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or to comply with study protocol

Both
4 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00778258
DAIT AADCRC-MSSM-02, DAIT 07-0563
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Hugh A. Sampson, MD Mount Sinai School of Medicine
Study Chair: Anna Nowak-Wegrzyn, MD Mount Sinai School of Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP