Overview

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