Actively Recruiting
Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
Led by George Washington University · Updated on 2025-12-04
18
Participants Needed
2
Research Sites
137 weeks
Total Duration
On this page
Sponsors
G
George Washington University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 18 and 45 years inclusive
- Good general health based on screening
- Available to participate for approximately 7.5 months
- Willing to sign informed consent and participate in the study
You will not qualify if you...
- Pregnant or breastfeeding females
- Females unwilling to use reliable contraception during the study if of reproductive potential
- History or evidence of significant neurologic, cardiac, lung, liver, rheumatologic, autoimmune, diabetes, or kidney disease
- Diagnosis of schizophrenia, bipolar disorder, or major psychiatric illness affecting study compliance
- Known or suspected immunodeficiency or immunosuppression
- Liver disease with ALT greater than 1.25 times upper limit
- Kidney disease with serum creatinine greater than 1.25 times upper limit
- Blood disorders including low hemoglobin, abnormal white blood cell, eosinophil, or platelet counts
- Positive fecal occult blood test
- Infection with pathogenic intestinal helminths
- History or lab evidence of iron deficiency anemia
- Alcohol or drug problems in past 24 months
- Positive tests for hepatitis B, HIV, or hepatitis C infections
- Use or planned use of corticosteroids or immunosuppressive drugs within 30 days before enrollment
- Allergy to albendazole
- Previous infection with Trichuris trichiura or residence over 6 months in an endemic area
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
2
NIH Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
D
David Diemert, MD
CONTACT
L
Laura Vasquez, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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