Clinical Trials
Researchers at the Jaffe Food Allergy Institute are performing cutting-edge research in virtually every facet of food-allergic disorders. Studies are ongoing to characterize the clinical features of a growing spectrum of food allergic disease, to understand why food allergy is increasing, and to determine better methods to diagnose, treat, and hopefully prevent these disorders. Numerous laboratory research studies, using the most advanced techniques available, are aimed at expanding our knowledge about immune mechanisms in food allergy and molecular characteristics of food allergens.
A summary of our ongoing research studies is available in our newsletter here. Each study is described so that you may determine if you or your child meets initial criteria for enrollment.
Study visits are held in the Clinical Research Unit (CRU), located on the second floor of 1184 Fifth Avenue. This patient care unit provides space for both inpatient and outpatient care and is staffed by Nurse Practitioners who will be working together with our Clinical Research Coordinators in supervising your or your child’s participation in research with the Jaffe Institute. Clinical protocols carried out in the CRU are supported through grants from the National Institutes of Health (NIH). As a result, there is no cost either to you or your insurance carrier.
Please do not hesitate to call us at (212) 241-5548 if you have any other questions or concerns that you would like to discuss.
Clinical Study of Chinese Herbal Medicine for Inflammatory Bowel Disease
Principal Investigator(s)Keith J. Benkov
Description
The purpose of this study is to see if inflammatory cytokines (markers or chemicals in the blood/tissue that are associated with active inflammatory bowel disease) will be effected by the addition of Chinese herbal medicines that are added to cultures of blood cells or tissue specimens from the colon. A blood sample will be drawn at the time of endoscopy. The blood sample will be used to obtain serum and white blood cells. The colonic (taken from the large intestine/colon) sample will be used to obtain tissue cells.
Contact Information
Kathy Hoffstadter-Thal
(212) 241-5415
kathy.hoffstadter-thal@mssm.edu
Peanut Epitope Study (ages 2- 50 years)
Principal Investigator(s)Hugh A. Sampson
Description
This study is being done to find out which specific parts of the peanut protein are most important in driving the allergic reaction to peanut, which is necessary to design better vaccine therapies. Participants are needed to help us as we work toward vaccine development. It involves a blood test and short questionnaire.
Contact Information
Jackie Fronda
(212) 241-0904
jaclyn.fronda@mssm.edu
Effect of Chinese Herbal Medicine on Food Allergy (ages 12-45 years)
Principal Investigator(s)Xiu-Min Li
Description
Food allergy is a growing and serious health concern in the United States and is now the leading cause of anaphylactic reactions. Peanut and tree nut allergies account for approximately 80% of fatal and near fatal anaphylactic reactions. At present, there is no definitive treatment for peanut or other food allergies. We generated Food Allergy Herbal Formula-2 (FAHF-2) derived from a traditional Chinese medicine formula. Phase I of this trial showed FAHF-2 was safe and well tolerated in people with multiple food allergies. This Phase II trial will determine the effectiveness of FAHF-2 when used as a treatment for food allergy. One may qualify for this study if s/he is between age 12-45 years old and has a food allergy to peanut, tree nut, sesame, fish, or shellfish. ClinicalTrials.gov Study Page
Contact Information
Jaime Ross
(212) 241-6577
jaime.ross@mssm.edu
Milk Oral Immunotherapy (OIT) plus Xolair® (anti-IgE) (ages 7-35 years)
Principal Investigator(s)Hugh A. Sampson
Description
Prior research has shown that milk oral immunotherapy has been effective in treating milk allergy. This study will help us learn about the safety and medical effects of milk oral immunotherapy (OIT) alone and together with omalizumab (Xolair®). The study will look at possible differences such as the amount of milk that can be tolerated during feeding tests while on milk OIT and side effects during therapy. All participants will get milk oral immunotherapy. ClinicalTrials.gov Study Page
Contact Information
Sally Noone
(212) 241-0336
sally.noone@mssm.edu
Food Allergy Resource Initiative (ages 6 months to 60 years)
Principal Investigator(s)Hugh A. Sampson
Description
This study is being done to see if we can determine what parts of food proteins are recognized by IgE (allergic) antibodies, which cause allergic reactions to foods. This information will be helpful in creating better diagnostic tests and treatments for food allergy in the future. It involves a blood test, a short questionnaire and may include an oral food challenge to establish a patient's food allergy.
Contact Information
Jackie Fronda
(212) 241-0904
jaclyn.fronda@mssm.edu
Baked Milk Study (ages 4-10 years)
Principal Investigator(s)Hugh A. Sampson
Description
In this study, we hope to find out if eating baked products that contain milk as an ingredient is safe for some children with milk allergy. We also hope to determine whether this changes the time it takes to outgrow milk allergy. ClinicalTrials.gov Study Page
Contact Information
Beth Strong
(212) 241-0957
beth.strong@mssm.edu
Food Protein-Induced Enterocolitis Syndrome - FPIES (ages 6 months-21 years)
Principal Investigator(s)Anna Nowak-Wegrzyn
Description
The purpose of this study is to describe the course of food protein-induced enterocolitis syndrome (FPIES), a specific type of food allergy that results in severe vomiting, to find out when and how FPIES is outgrown. We also hope to determine if laboratory tests can be developed to distinguish when children outgrow FPIES.
Contact Information
Sally Noone
(212) 241-0336
sally.noone@mssm.edu
Anaphylaxis Therapies (ages 0-17 years)
Principal Investigator(s)Anna Nowak-Wegrzyn
Description
With this study, we hope to learn more about the use of auto-injectable epinephrine (TwinJect®/EpiPen®). We are trying to find out which patients may require more than one dose of epinephrine for an allergic reaction to food, and why they may need an additional dose.
Contact Information
Joanna Lis
(212) 241-7099
joanna.lis@mssm.edu
Tel: 212-241-5548
Fax: 212-426-1902
Jaffe Food Allergy Institute
5 East 98th Street, 10th Floor
New York, NY 10029
Fall 2012 [PDF]