Crohn DiseaseNCT02399683
Immune Modulation From Trichuris Trichiura
An observational study of Crohn Disease and Colitis, Ulcerative, run by University of Aarhus.
Trial summary
Mucosal immunology during helminth infection Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Colitis, Ulcerative, Intestinal Helminthiasis
- What is being tested?
- Trichuris trichiura eggs
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A single healthy volunteer
Who may be able to join
- 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.
Who cannot join
- N/A
About this study
Official title: Mucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected Individual
Mucosal immunology during helminth infection
Read the detailed description
The present study investigates the effects of Trichuris trichiura on human mucosal and systemic immunity in a single self-infected individual.
- Conditions
- Crohn Disease, Colitis, Ulcerative, Intestinal Helminthiasis
- Being tested
- Trichuris trichiura eggs
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Intestinal helminthiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichuris trichiura eggsBiological
Live eggs from human whipworm, Trichuris trichiura
| Study group | Role | What they receive |
|---|---|---|
| Trichuris trichiura eggs | One healthy volunteer Receives: Biological: Trichuris trichiura eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal egg excretion
Weekly monitoring of fecal egg counts by microscopy
Measured: 30 weeks
Secondary outcomes (3)
Mucosal T cell associated cytokines
Biopsy sampling during established infection
Measured: Week 15
Systemic immune parameters (eosinophilia, Subtypes of circulating T cells)
Weekly monitoring
Measured: 30 weeks
Adverse events
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.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Hvas, University of Aarhus
- Investigators
- Jens F Dahlerup, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399683
- Sponsor's protocol ID
- Trichuris trichiura
- Status last verified
- Nov 2016
- First submitted
- 12 Mar 2015
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected Individual
- ClinicalTrials.gov ID
- NCT02399683
- Acronym / sponsor ID
- Trichuris trichiura
- Conditions
- Crohn Disease, Colitis, Ulcerative, Intestinal Helminthiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mucosal immunology during helminth infection
Detailed description
The present study investigates the effects of Trichuris trichiura on human mucosal and systemic immunity in a single self-infected individual.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trichuris trichiura eggs | – | Biological: Trichuris trichiura eggsOne healthy volunteer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A single healthy volunteer
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trichuris trichiura eggsLive eggs from human whipworm, Trichuris trichiura | Biological | Trichuris trichiura eggs |
Primary outcome
Faecal egg excretion
Time frame: 30 weeks
Weekly monitoring of fecal egg counts by microscopy
3 secondary outcomes
Mucosal T cell associated cytokines
Time frame: Week 15
Systemic immune parameters (eosinophilia, Subtypes of circulating T cells)
Time frame: 30 weeks
Adverse events
Time frame: 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens F Dahlerup, MD principal investigator
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Colitis, Ulcerative, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal egg excretion (time frame: 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.