NCT03079700

Brief Summary

Mucosal immunology during helminth infection

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2012

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

March 9, 2017

Last Update Submit

March 9, 2017

Conditions

Crohn DiseaseUlcerative ColitisIntestinal Helminthiasis

Outcome Measures

Primary Outcomes (1)

  • Faecal egg excretion

    Weekly monitoring of fecal egg counts by microscopy

    15 weeks

Secondary Outcomes (3)

  • Mucosal T cell associated cytokines

    15 weeks

  • Systemic immune parameters (eosinophilia, Subtypes of circulating T cells)

    15 weeks

  • Adverse events

    15 weeks

Interventions

Trichuris suis eggsBIOLOGICAL

Live eggs from swine whipworm, Trichuris suis

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A single healthy volunteer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood cell and intestinal biopsies

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeIntestinal helminthiasis

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 14, 2017

Study Start

August 1, 2012

Primary Completion

December 31, 2012

Study Completion

December 31, 2012

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share