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NCT03079700 Clinical Trial

Immune Modulation From Trichuris Suis

Ulcerative Colitis Clinical Trial

Official title:
Mucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected Individual

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03079700
Other study ID # Trichuris suis
Secondary ID
Status Completed
Phase N/A
First received March 9, 2017
Last updated March 9, 2017
Start date August 1, 2012
Est. completion date December 31, 2012

Study information
Verified date March 2017
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mucosal immunology during helminth infection

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date December 31, 2012
Est. primary completion date December 31, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Outcome
Type Measure Description Time frame Safety issue
Primary Faecal egg excretion Weekly monitoring of fecal egg counts by microscopy 15 weeks
Secondary Mucosal T cell associated cytokines Biopsy sampling during established infection 15 weeks
Secondary Systemic immune parameters (eosinophilia, Subtypes of circulating T cells) Blood samples every week 15 weeks
Secondary Adverse events Clinical evaluation every week 15 weeks
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