Healthy volunteers swallow whipworm eggs for science
NCT ID NCT05706116
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether giving healthy adults a controlled dose of whipworm eggs is safe and can cause a mild infection. Researchers will try different egg doses in 18 volunteers to find the best balance of safety and infection. The goal is to create a reliable human infection model for future studies on whipworm and potential treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or females between 18 and 45 years, inclusive. 2. Good general health as determined by means of the screening procedures. 3. Available for the duration of the trial (approximately 7.5 months). 4. Willingness to participate in the study as evidenced by signing the informed consent document. 5. Ability to sign and understand the informed consent document. Exclusion Criteria: 1. Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female). 2. Participant unwilling to use reliable contraception methods while participating in the study (if female of reproductive potential who is engaging in sexual activity that could lead to pregnancy); being of reproductive potential is defined as not being surgically sterile, abstinent from intercourse with a male partner, in a monogamous relationship with a vasectomized partner, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile. 3. Currently lactating and breast-feeding (if female). 4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies. 5. Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits/procedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide). 6. Known or suspected immunodeficiency or immunosuppression as a result of an underlying illness or treatment. 7. Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit). 8. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit). 9. Laboratory evidence of hematologic disease (hemoglobin \<11.1 g/dl \[females\] or \<12.5 g/dl \[males\]; absolute leukocyte count \<3.4 or \>11.0 x 103/mm3; absolute eosinophil count \>0.6 x 103/mm3 or platelet count \<125 x 103/mm3). 10. Positive fecal occult blood test. 11. Infection with a pathogenic intestinal helminth as determined by stool examination for ova and parasites. 12. History of iron deficiency anemia or laboratory evidence of iron deficiency (serum ferritin concentration below the lower reference limit). 13. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the participant unable to comply with the protocol. 14. Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 24 months. 15. Positive ELISA for hepatitis B surface antigen (HBsAg). 16. Positive confirmatory test for HIV infection. 17. Positive confirmatory test for hepatitis C virus (HCV) infection. 18. Using or intends to continue using oral or parenteral corticosteroids, high-dose inhaled corticosteroids (\>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs within 30 days of the volunteer's expected enrollment in this study or planned use during the study. 19. Known allergy to albendazole. 20. History of previous infection with T. trichiura or continuous residence for more than 6 months in a T. trichiura-endemic area. 21. Inability to speak English. 22. Current/planned simultaneous participation in another study of an investigational agent or device for the duration of their study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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George Washington University Medical Faculty Associates
RECRUITINGWashington D.C., District of Columbia, 20037, United States
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NIH Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Nose drops of pneumonia bacteria could pave way for better vaccines
- Could a Two-Drug combo beat whipworm in kids?
- New combo drug doses aim to wipe out whipworm in toddlers
- Could a Two-Drug punch finally knock out whipworm in kids?