Trichuris Suis Ova in Peanut and Tree Nut Allergy
The goal of this study is to determine whether Trichuris suis ova, a potential immunomodulator, is safe in adults and children allergic to peanut or tree nuts.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Trichuris Suis Ova Therapy for Mild to Moderate Peanut and Tree Nut Allergy in Adults and Children|
- Occurrence of unexpected severe side effects [ Time Frame: every 2 weeks during the entire duration of the study ] [ Designated as safety issue: Yes ]Evidence of unexpected severe side effects due to the study medication.
|Study Start Date:||February 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: Trichuris suis ova (TSO)||
Drug: Trichuris suis ova (TSO)
Subjects will receive TSO every other week for 3 months. The dose will depend on the age of the subject and vary between 100 and 2500 eggs. TSO will be administered orally as a suspension in single dose vials prepared by Ovamed GmbH, a company not directly involved in the study.
Food allergy is a major cause of life-threatening hypersensitivity reactions. Currently avoidance of the allergenic food is the only established method of preventing reactions in allergic patients. This situation impacts significantly the lives of patients, mainly children, and their families. The current increase in the prevalence of allergic diseases, food allergy in particular, in the Western world has been attributed in part to changes in life style. Before the mid 20th century individuals were exposed to numerous bacterial, parasitic and viral agents. Since these times the progress of hygiene has considerably reduced the risk of exposure to these agents. It is thought that this lack of exposure, particularly during childhood, has led to subtle changes in humans' immune system resulting in an increased propensity to develop allergic and autoimmune responses, the so-called hygiene hypothesis. One of the means of reverting this propensity could be exposure to harmless biological agents. One such agent, eggs of the parasite Trichuris suis (Trichuris suis ova, TSO), has been shown to be well tolerated and efficient in patients with inflammatory bowel diseases. This phase I study will assess whether TSO is safe in adults and children with peanut or tree nut allergy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070498
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Marie-Helene Jouvin, MD||Beth Israel Deaconess Medical Center|