Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05706116 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 32 wordsv13
  2. Primary completion date: Oct 23, 2026 to Oct 23, 2027
    • Start date changed from estimate of Oct 2025 to Sep 10, 2025
    v12
  3. Start date: Jul 2025 to Oct 2025v11
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2025 to Jul 2025
    • Site details revised at 2 of 2 sites
    v10
  5. Start date: Jan 2025 to Mar 2025v9
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: Oct 1, 2024 to Jan 2025v8
  2. Start date: Jul 1, 2024 to Oct 1, 2024
    • Primary completion date: Jul 23, 2026 to Oct 23, 2026
    • Study completion date: Jan 30, 2028 to Apr 30, 2028
    v7
  3. Start date: Feb 1, 2024 to Jul 1, 2024
    • Primary completion date: Feb 23, 2026 to Jul 23, 2026
    • Study completion date: Sep 30, 2027 to Jan 30, 2028
    v6
  4. Start date: Oct 1, 2023 to Feb 1, 2024
    • Primary completion date: Sep 23, 2025 to Feb 23, 2026
    • Study completion date: Mar 30, 2026 to Sep 30, 2027
    v5
  5. Start date: Jul 1, 2023 to Oct 1, 2023
    • Primary completion date: Jun 23, 2025 to Sep 23, 2025
    • Study completion date: Dec 30, 2025 to Mar 30, 2026
    v4
  6. Primary completion date: Dec 23, 2024 to Jun 23, 2025
    • Start date: Mar 1, 2023 to Jul 1, 2023
    • Study completion date: Aug 30, 2025 to Dec 30, 2025
    v3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05706116
Lead Sponsor George Washington University
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Whipworm, Trichuriasis, Controlled Human Infection
Related terms Trichuriasis
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov