Immune Modulation From Trichuris Trichiura

Crohn Disease Clinical Trial

Official title:

Mucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected Individual

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399683
• Other study ID #: Trichuris trichiura
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: November 18, 2016
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Mucosal immunology during helminth infection

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2012
• Est. primary completion date: December 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

Observational Model: Case-Only

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Helminthiasis
• Intestinal Diseases, Parasitic
• Intestinal Helminthiasis

Intervention

Biological:
• Trichuris trichiura eggs
Live eggs from human whipworm, Trichuris trichiura

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	30 weeks	No
Secondary	Mucosal T cell associated cytokines	Biopsy sampling during established infection	Week 15	No
Secondary	Systemic immune parameters (eosinophilia, Subtypes of circulating T cells)	Weekly monitoring	30 weeks	No
Secondary	Adverse events	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.	30 weeks	Yes