Trichuris Suis Ova in Peanut and Tree Nut Allergy (NCT01070498) | Clinical Trial Compass
CompletedPhase 1
Trichuris Suis Ova in Peanut and Tree Nut Allergy
United States18 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ren…
What they're measuring
1
Occurrence of unexpected severe side effects
Timeframe: every 2 weeks during the entire duration of the study