Trial record 6 of 9 for:    AADCRC

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
  Purpose

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.


Condition Intervention Phase
Food Hypersensitivity
Milk Hypersensitivity
Biological: Baked Milk
Biological: Non-baked Milk
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dietary Intervention in Milk Allergy and Tolerance Development

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 160
Study Start Date: August 2008
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.
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.
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: Tolerant to Baked and Non-baked Milk 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.
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.

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778258

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Investigators
Study Chair: Hugh A. Sampson, MD Mount Sinai School of Medicine
Study Chair: Anna Nowak-Wegrzyn, MD Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00778258     History of Changes
Other Study ID Numbers: DAIT AADCRC-MSSM-02, DAIT 07-0563
Study First Received: October 21, 2008
Last Updated: October 24, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Food Allergy
Milk Allergy

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on October 01, 2014