Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults (NCT05706116) | Clinical Trial Compass
RecruitingPhase 1
Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
United States18 participantsStarted 2025-09-10
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females between 18 and 45 years, inclusive.
. Good general health as determined by means of the screening procedures.
. Available for the duration of the trial (approximately 7.5 months).
. Willingness to participate in the study as evidenced by signing the informed consent document.
. Ability to sign and understand the informed consent document.
Exclusion criteria
. Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Solicited adverse events, graded by severity
Timeframe: Day of CHTI through study Day 182
2
Serious Adverse Events
Timeframe: Day of CHTI through final study visit on study Day 203
3
Unsolicited adverse events
Timeframe: Day of CHTI through study Day 182
4
New-onset chronic medical conditions
Timeframe: Day of CHTI through final study visit on study Day 203
5
Adverse Events of Special Interest
Timeframe: Day of CHTI through final study visit on study Day 203
6
Adverse events related to abnormal clinical safety laboratory parameter (white blood cell count) values
Timeframe: Day of CHTI through final study visit on study Day 203
7
Adverse events related to abnormal clinical safety laboratory parameter (absolute eosinophil count) values
Timeframe: Day of CHTI through final study visit on study Day 203
. 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.
. Currently lactating and breast-feeding (if female).
. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
. 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).
. Known or suspected immunodeficiency or immunosuppression as a result of an underlying illness or treatment.
. Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit).
8
Adverse events related to abnormal clinical safety laboratory parameter (platelet count) values
Timeframe: Day of CHTI through final study visit on study Day 203
9
Adverse events related to abnormal clinical safety laboratory parameter (hemoglobin concentration) values
Timeframe: Day of CHTI through final study visit on study Day 203
10
Adverse events related to abnormal clinical safety laboratory parameter (serum creatinine concentration) values
Timeframe: Day of CHTI through final study visit on study Day 203
11
Adverse events related to abnormal clinical safety laboratory parameter (serum alanine aminotransferase concentration) values
Timeframe: Day of CHTI through final study visit on study Day 203