Immune Modulation From Trichuris Suis

March 9, 2017 updated by: Christian Hvas, University of Aarhus

Mucosal and Systemic Immune Modulation From Trichuris Suis 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 suis 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

No

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:

-

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Faecal egg excretion
Time Frame: 15 weeks
Weekly monitoring of fecal egg counts by microscopy
15 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University of Aarhus

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 (Actual)

August 1, 2012

Primary Completion (Actual)

December 31, 2012

Study Completion (Actual)

December 31, 2012

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trichuris suis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Crohn Disease

Clinical Trials on Trichuris suis eggs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe