Immune Modulation From Trichuris Trichiura

Completed

• Conditions: Colitis, Ulcerative; Crohn Disease; Intestinal Helminthiasis
• Interventions: Biological: Trichuris trichiura eggs

• Registration Number: NCT02399683
• Lead Sponsor: University of Aarhus

Brief Summary

Mucosal immunology during helminth infection

Detailed Description

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

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

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

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trichuris trichiura eggs	Trichuris trichiura eggs	One healthy volunteer

Primary Outcome Measures

Name	Time	Method
Faecal egg excretion	30 weeks	Weekly monitoring of fecal egg counts by microscopy

Secondary Outcome Measures

Name	Time	Method
Mucosal T cell associated cytokines	Week 15	Biopsy sampling during established infection
Systemic immune parameters (eosinophilia, Subtypes of circulating T cells)	30 weeks	Weekly monitoring
Adverse events	30 weeks	The included individual was monitored clinically every week for the development of diarrhea and weight loss, and by blood samples for anemia and inflammatory parameters every other week.