Immune Modulation From Trichuris Suis

Completed

• Conditions: Ulcerative Colitis; Crohn Disease; Intestinal Helminthiasis

• Registration Number: NCT03079700
• Lead Sponsor: University of Aarhus

Brief Summary

Mucosal immunology during helminth infection

Detailed Description

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

Study Timeline

• Study Start: 2012-08-01
• Primary Completion: 2012-12-31
• Study Completion: 2012-12-31
• Status Verified: 2017-03
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Study First Posted: 2017-03-14
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

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.

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Faecal egg excretion	15 weeks	Weekly monitoring of fecal egg counts by microscopy

Secondary Outcome Measures

Name	Time	Method
Systemic immune parameters (eosinophilia, Subtypes of circulating T cells)	15 weeks	Blood samples every week
Mucosal T cell associated cytokines	15 weeks	Biopsy sampling during established infection
Adverse events	15 weeks	Clinical evaluation every week