Trichuris Suis Ova in Peanut and Tree Nut Allergy

Completed · Phase 1

Conditions studied: Food Allergy

In brief

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.

Key facts

Study ID

NCT01070498

Run by

Beth Israel Deaconess Medical Center

People needed

18

Starts

2010-02-01

Expected to finish

2011-12-01

Last updated by the study team

2017-02-03

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.