NCT01070498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

February 17, 2010

Last Update Submit

February 2, 2017

Conditions

Food Allergy

Keywords

peanut hypersensitivitytree nut hypersensitivityallergyTrichuris suishygiene hypothesistreatmentclinical trialfood/adverse effectpeanut allergy (mild to moderate)tree nut allergy (mild to moderate)

Outcome Measures

Primary Outcomes (1)

  • Occurrence of unexpected severe side effects

    Evidence of unexpected severe side effects due to the study medication.

    every 2 weeks during the entire duration of the study

Study Arms (1)

Trichuris suis ova (TSO)

EXPERIMENTAL
Drug: Trichuris suis ova (TSO)

Interventions

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.

Trichuris suis ova (TSO)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Food HypersensitivityPeanut HypersensitivityNut HypersensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateImmune System DiseasesNut and Peanut Hypersensitivity

Study Officials

  • Marie-Helene Jouvin, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 18, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

US(1)