NCT02399683

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 Feb 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

March 12, 2015

Last Update Submit

November 18, 2016

Conditions

Crohn DiseaseColitis, UlcerativeIntestinal Helminthiasis

Outcome Measures

Primary Outcomes (1)

  • Faecal egg excretion

    Weekly monitoring of fecal egg counts by microscopy

    30 weeks

Secondary Outcomes (3)

  • Mucosal T cell associated cytokines

    Week 15

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

    30 weeks

  • Adverse events

    30 weeks

Study Arms (1)

Trichuris trichiura eggs

One healthy volunteer

Biological: Trichuris trichiura eggs

Interventions

Trichuris trichiura eggsBIOLOGICAL

Live eggs from human whipworm, Trichuris trichiura

Trichuris trichiura eggs

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

You may not qualify if:

  • N/A

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 Officials

  • Jens F Dahlerup, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 26, 2015

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 21, 2016

Record last verified: 2016-11