Trichuris Suis Ova in Peanut and Tree Nut Allergy

This study has been completed.
Sponsor:
Collaborator:
Food Allergy Initiative
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01070498
First received: February 17, 2010
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Food Allergy
Drug: Trichuris suis ova (TSO)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trichuris Suis Ova Therapy for Mild to Moderate Peanut and Tree Nut Allergy in Adults and Children

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Occurrence of unexpected severe side effects [ Time Frame: every 2 weeks during the entire duration of the study ] [ Designated as safety issue: Yes ]
    Evidence of unexpected severe side effects due to the study medication.


Estimated Enrollment: 18
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trichuris suis ova (TSO) Drug: Trichuris suis ova (TSO)
Subjects will receive TSO every other week for 3 months. The dose will depend on the age of the subject and vary between 100 and 2500 eggs. TSO will be administered orally as a suspension in single dose vials prepared by Ovamed GmbH, a company not directly involved in the study.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070498

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Food Allergy Initiative
Investigators
Principal Investigator: Marie-Helene Jouvin, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01070498     History of Changes
Other Study ID Numbers: FAI-TSO-1
Study First Received: February 17, 2010
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
peanut hypersensitivity
tree nut hypersensitivity
allergy
Trichuris suis
hygiene hypothesis
treatment
clinical trial
food/adverse effect
peanut allergy (mild to moderate)
tree nut allergy (mild to moderate)

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Nut Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 29, 2014