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NCT05706116 · ClinicalTrials.gov registry record · Phase 1
Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
A Phase 1 study of Whipworm and Trichuriasis, sponsored by George Washington University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT05706116 is a Phase 1 study of Whipworm and Trichuriasis that is actively recruiting participants, run by George Washington University. The registered enrollment target is 18 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT05706116, a Phase 1 study of Whipworm and Trichuriasis, is actively recruiting participants, sponsored by George Washington University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
A Controlled Human Infection Model (CHIM) is being developed to provide early proof-of-concept that experimental infection with the intestinal nematode, Trichuris trichiura, is feasible and safe. The proposed model consists of enrolling consenting, healthy, trichuriasis-naïve adults and challenging them with the investigational product, Trichuris trichiura Egg Inoculum, to assess their ability to result in detectable infection. The proposed study will be a feasibility study that will consist of administering different doses of the Trichuris trichiura Egg Inoculum to healthy adult volunteers to determine the optimal dose (i.e., number of T. trichiura eggs) that is safe, well-tolerated and results in consistent infection.
Conditions Studied
Interventions
- BIOLOGICAL Trichuris trichiura Egg Inoculum
Study Locations (2)
District of Columbia
- George Washington University Medical Faculty Associates - Washington D.C.
Maryland
- NIH Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-09-10 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05706116
The ClinicalTrials.gov registry entry for NCT05706116 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Whipworm appearing as the primary indexed condition, and to 1 intervention - of which Trichuris trichiura Egg Inoculum is the first listed.
NCT05706116 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT05706116 about?
NCT05706116 is a clinical study titled "Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults". A Controlled Human Infection Model (CHIM) is being developed to provide early proof-of-concept that experimental infection with the intestinal nematode, Trichuris trichiura, is feasible and safe. The proposed model consists of enrolling consenting, healthy, trichuriasis-naïve adults and challenging ...
What is the current status of trial NCT05706116?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-09-10. Estimated completion is 2028-04-30.
What conditions does trial NCT05706116 study?
This clinical trial studies the following conditions: Whipworm, Trichuriasis, Controlled Human Infection.
What interventions are being tested in trial NCT05706116?
The interventions under investigation include: Trichuris trichiura Egg Inoculum (BIOLOGICAL).
Who is sponsoring clinical trial NCT05706116?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05706116 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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