Trichuris Suis Ova in Peanut and Tree Nut Allergy

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Food Allergy Initiative

Criteria

Inclusion Criteria:

• 18 to 64 years old

• Positive skin-prick test to peanut or tree nut and a history of significant clinical symptoms within 60 minutes after the ingestion of peanuts or tree nuts.

• Peanut or tree nut allergy of mild to moderate grade based on the presence of localized or generalized erythema/urticaria/angioedema/oral pruritis, gastrointestinal symptoms, rhinoconjunctivitis, or mild laryngeal edema (voice change/tightening of throat/mild asthma), and the absence of symptoms/signs of severity (marked dyspnea, hypoxia, cyanosis, hypotension, confusion, incontinence, collapse or loss of consciousness)

• Otherwise in good health

• Ability to provide written informed consent

Exclusion Criteria:

• History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (cyanosis or SpO2 < 92% at any stage, confusion, collapse, loss of consciousness, or incontinence)

• Poor control of atopic dermatitis or current flare requiring an increase in atopic dermatitis medication

• Inability to discontinue antihistaminic for skin testing

• Severe persistent asthma as defined by the NHLBI criteria

• Asthma that requires oral steroids

• Asthma that has been controlled for less than 1 year

• FEV1<80% at the screening visit or immediately before the 1st administration of TSO

• Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the NHLBI guidelines

• Abnormal blood cell count

• Abnormal renal function (creatinine above twice the upper limit of normal range)

• Abnormal hepatic tests (AST, ALT above twice the upper limit of normal range)

• Allergy to Trichuris species

• Currently treated with anti-helminthic medication

• Previous treatment with immunosuppressive therapy, cytotoxic chemotherapy or lymphoid irradiation for any reason

• Insulin dependent diabetes

• History of HIV-1, HTLV-1 or Lyme disease

• Significant physical or mental disease that would preclude successful compliance and participation in the study, or, in the opinion of the investigators, constitute a hazard, such that enrollment in the study would not be in the subject's best interest

• Presence or history of cancer of any type except successfully treated basal cell or squamous cell carcinoma of the skin

• History of alcohol or drug abuse in the last 12 months; chronic liver or biliary disease

• Pregnancy and lactation; women of child bearing potential must have a documented negative pregnancy test at entry and at each visit during the study, and must be willing to practice adequate birth control during the duration of the study

• History of parasitism or positive stool determination for ova or parasite at screening

• Unwillingness or inability of patients (or caregivers) to give written consent or to follow the protocol successfully, including coming to the clinic every 2 weeks for about 4 months

• Currently participating in a study using an investigational new drug

• Participation in any interventional study for the treatment of food allergy in the past 6 months

• Presence in the household of an immunodeficient or immunosuppressed individual