Trichuris Suis Ova in Peanut and Tree Nut Allergy

Beth Israel Lahey Health

Status and phase

Completed

Phase 1

Conditions

Food Allergy

Treatments

Drug: Trichuris suis ova (TSO)

Study type

Interventional

Funder types

Other

Identifiers

NCT01070498

2009P000414

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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