Crohn Disease Clinical Trial
Official title:
Mucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected Individual
Verified date | November 2016 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Observational |
Mucosal immunology during helminth infection
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: |
Observational Model: Case-Only
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
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 |
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