Food AllergyPhase 1NCT01070498
Trichuris Suis Ova in Peanut and Tree Nut Allergy
A Phase 1 study testing Trichuris suis ova (TSO) in people with Food Allergy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Trichuris suis ova (TSO)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: Trichuris Suis Ova Therapy for Mild to Moderate Peanut and Tree Nut Allergy in Adults and Children
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.
Read the 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.
- Conditions
- Food Allergy
- Being tested
- Trichuris suis ova (TSO)
- 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)
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity, Nut Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichuris suis ova (TSO)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Trichuris suis ova (TSO) | Experimental | Not described Receives: Drug: Trichuris suis ova (TSO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of unexpected severe side effects
Evidence of unexpected severe side effects due to the study medication.
Measured: every 2 weeks during the entire duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Food Allergy Initiative
- Responsible party
- Sponsor
- Investigators
- Marie-Helene Jouvin, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070498
- Sponsor's protocol ID
- 2009P000414
- Status last verified
- Feb 2017
- First submitted
- 17 Feb 2010
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trichuris Suis Ova Therapy for Mild to Moderate Peanut and Tree Nut Allergy in Adults and Children
- ClinicalTrials.gov ID
- NCT01070498
- Acronym / sponsor ID
- 2009P000414
- Conditions
- Food Allergy
- Keywords
- peanut hypersensitivity, tree nut hypersensitivity, allergy, Trichuris suis, hygiene hypothesis, treatment, clinical trial, food/adverse effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Food Allergy Initiative
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trichuris suis ova (TSO) | Experimental | Drug: Trichuris suis ova (TSO) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Trichuris suis ova (TSO) |
Primary outcome
Occurrence of unexpected severe side effects
Time frame: every 2 weeks during the entire duration of the study
Evidence of unexpected severe side effects due to the study medication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Helene Jouvin, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trichuris suis ova (TSO) in people with Food Allergy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of unexpected severe side effects (time frame: every 2 weeks during the entire duration of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.