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Immune Modulation From Trichuris Suis

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ClinicalTrials.gov Identifier: NCT03079700
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Christian Hvas, University of Aarhus

Brief Summary:
Mucosal immunology during helminth infection

Condition or disease Intervention/treatment
Crohn Disease Ulcerative Colitis Intestinal Helminthiasis Biological: Trichuris suis eggs

Detailed Description:
The present study investigates the effects of Trichuris suis on human mucosal and systemic immunity in a single self-infected individual.

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected Individual
Actual Study Start Date : August 1, 2012
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : December 31, 2012

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Trichuris suis eggs
    Live eggs from swine whipworm, Trichuris suis


Primary Outcome Measures :
  1. Faecal egg excretion [ Time Frame: 15 weeks ]
    Weekly monitoring of fecal egg counts by microscopy


Secondary Outcome Measures :
  1. Mucosal T cell associated cytokines [ Time Frame: 15 weeks ]
    Biopsy sampling during established infection

  2. Systemic immune parameters (eosinophilia, Subtypes of circulating T cells) [ Time Frame: 15 weeks ]
    Blood samples every week

  3. Adverse events [ Time Frame: 15 weeks ]
    Clinical evaluation every week


Biospecimen Retention:   Samples With DNA
Blood cell and intestinal biopsies


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A single healthy volunteer
Criteria

Inclusion Criteria:

  • The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his inclusion in the study was that he was healthy.

Exclusion Criteria:


Responsible Party: Christian Hvas, MD PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT03079700     History of Changes
Other Study ID Numbers: Trichuris suis
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Helminthiasis
Intestinal Diseases, Parasitic
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Parasitic Diseases