Clinical Trial: Trichuris Suis Ova in Peanut and Tree Nut Allergy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Trichuris Suis Ova Therapy for Mild to Moderate Peanut and Tree Nut Allergy in Adults and Children

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Beth Israel Deaconess Medical Center

Current Primary Outcome: Occurrence of unexpected severe side effects [ Time Frame: every 2 weeks during the entire duration of the study ]

Evidence of unexpected severe side effects due to the study medication.


Original Primary Outcome: occurrence of unexpected side effects [ Time Frame: throughout the study ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: February 17, 2010
Date Started: February 2010
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017