Working… Menu

Immune Modulation From Trichuris Suis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03079700
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : March 14, 2017
Information provided by (Responsible Party):
Christian Hvas, University of Aarhus

Brief Summary:
Mucosal immunology during helminth infection

Condition or disease Intervention/treatment
Crohn Disease Ulcerative Colitis Intestinal Helminthiasis Biological: Trichuris suis eggs

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected Individual
Actual Study Start Date : August 1, 2012
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : December 31, 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Biological: Trichuris suis eggs
    Live eggs from swine whipworm, Trichuris suis

Primary Outcome Measures :
  1. Faecal egg excretion [ Time Frame: 15 weeks ]
    Weekly monitoring of fecal egg counts by microscopy

Secondary Outcome Measures :
  1. Mucosal T cell associated cytokines [ Time Frame: 15 weeks ]
    Biopsy sampling during established infection

  2. Systemic immune parameters (eosinophilia, Subtypes of circulating T cells) [ Time Frame: 15 weeks ]
    Blood samples every week

  3. Adverse events [ Time Frame: 15 weeks ]
    Clinical evaluation every week

Biospecimen Retention:   Samples With DNA
Blood cell and intestinal biopsies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A single healthy volunteer

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:


Layout table for additonal information
Responsible Party: Christian Hvas, MD PhD, University of Aarhus Identifier: NCT03079700     History of Changes
Other Study ID Numbers: Trichuris suis
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Parasitic Diseases