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RECRUITING Phase 1

Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults

NCT05706116 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 18 participants
Start Date 2025-09-10
Est. Completion 2028-04-30
Phase Phase 1

Sponsor

George Washington University

134 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05706116 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05706116?

The interventions under investigation include: Trichuris trichiura Egg Inoculum (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05706116?

This trial is sponsored by George Washington University, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial