Immune Modulation From Trichuris Trichiura

November 18, 2016 updated by: Christian Hvas, University of Aarhus

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

Mucosal immunology during helminth infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

A single healthy volunteer

Description

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:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trichuris trichiura eggs
One healthy volunteer
Biological: Trichuris trichiura eggs
Live eggs from human whipworm, Trichuris trichiura

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Faecal egg excretion
Time Frame: 30 weeks
Weekly monitoring of fecal egg counts by microscopy
30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucosal T cell associated cytokines
Time Frame: Week 15
Biopsy sampling during established infection
Week 15
Systemic immune parameters (eosinophilia, Subtypes of circulating T cells)
Time Frame: 30 weeks
Weekly monitoring
30 weeks
Adverse events
Time Frame: 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.
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Jens F Dahlerup, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (ESTIMATE)

March 26, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trichuris trichiura

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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