Trichuris Suis Ova in Peanut and Tree Nut Allergy
Primary Purpose
Food Allergy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Trichuris suis ova (TSO)
Sponsored by
About this trial
This is an interventional treatment trial for Food Allergy focused on measuring 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)
Eligibility 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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trichuris suis ova (TSO)
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of unexpected severe side effects
Evidence of unexpected severe side effects due to the study medication.
Secondary Outcome Measures
Full Information
NCT ID
NCT01070498
First Posted
February 17, 2010
Last Updated
February 2, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Food Allergy Initiative
1. Study Identification
Unique Protocol Identification Number
NCT01070498
Brief Title
Trichuris Suis Ova in Peanut and Tree Nut Allergy
Official Title
Trichuris Suis Ova Therapy for Mild to Moderate Peanut and Tree Nut Allergy in Adults and Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Food Allergy Initiative
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
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)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trichuris suis ova (TSO)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Trichuris suis ova (TSO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of unexpected severe side effects
Description
Evidence of unexpected severe side effects due to the study medication.
Time Frame
every 2 weeks during the entire duration of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Helene Jouvin, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
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Trichuris Suis Ova in Peanut and Tree Nut Allergy
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