Trichuris trichiura Eggs for Whipworm Infection

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: George Washington University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Healthy adults aged 18-45 who have never had a whipworm infection can join this trial. They must be in good health, not pregnant or breastfeeding, willing to use contraception if applicable, and available for about 7.5 months. People with immune deficiencies, liver or kidney issues, substance abuse history within the last two years, certain psychiatric conditions, blood disorders or other significant health problems cannot participate.

Inclusion Criteria

Willingness to participate in the study as evidenced by signing the informed consent document

Available for the duration of the trial (approximately 7.5 months)

Good general health as determined by means of the screening procedures

Exclusion Criteria

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

Currently lactating and breast-feeding (if female)

Infection with a pathogenic intestinal helminth as determined by stool examination for ova and parasites

Treatment Details

Interventions

• Trichuris trichiura Egg Inoculum (Virus Therapy)

Trial Overview The study is testing the safety of swallowing Trichuris trichiura eggs (a type of worm) to see if it causes a controlled infection without harm. Participants will take different doses to find the safest amount that still leads to detectable whipworm infection.

Participant Groups

Group I: Trichuris trichiura Egg Inoculum 450 eggs Experimental Treatment 1 Intervention

450 Trichuris trichiura eggs

Group II: Trichuris trichiura Egg Inoculum 300 eggs Experimental Treatment 1 Intervention

300 Trichuris trichiura eggs

Group III: Trichuris trichiura Egg Inoculum 150 eggs Experimental Treatment 1 Intervention

150 Trichuris trichiura eggs

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+