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OpenTrials
Completed

NCT Number: NCT02399683

Immune Modulation From Trichuris Trichiura

Mucosal immunology during helminth infection

Completed

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Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Intestinal Helminthiasis

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trichuris trichiura eggs

Biological

Live eggs from human whipworm, Trichuris trichiura

Primary outcomes

  1. Faecal egg excretion

    Time frame: 30 weeks

    Weekly monitoring of fecal egg counts by microscopy

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2015
Registry last updated
Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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