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Immune Modulation From Trichuris Trichiura

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ClinicalTrials.gov Identifier: NCT02399683
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Christian Hvas, University of Aarhus

Brief Summary:
Mucosal immunology during helminth infection

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

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

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Official Title: Mucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected Individual
Study Start Date : February 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Faecal egg excretion [ Time Frame: 30 weeks ]
    Weekly monitoring of fecal egg counts by microscopy


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

  2. Systemic immune parameters (eosinophilia, Subtypes of circulating T cells) [ Time Frame: 30 weeks ]
    Weekly monitoring

  3. 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.


Biospecimen Retention:   Samples With DNA
Blood cell and intestinal biopsies


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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399683


Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Jens F Dahlerup, MD Aarhus University Hospital

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Responsible Party: Christian Hvas, MD, Ph.D., University of Aarhus
ClinicalTrials.gov Identifier: NCT02399683     History of Changes
Other Study ID Numbers: Trichuris trichiura
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Helminthiasis
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Parasitic Diseases