Trichuris trichiura Eggs for Whipworm Infection

Recruiting at 2 trial locations

Overseen By Laura Vasquez, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: George Washington University

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Pregnancy, Neurologic, Cardiac, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether exposure to Trichuris trichiura eggs (Trichuris trichiura Egg Inoculum) can safely cause a mild, controlled infection in healthy adults. The aim is to determine if the eggs produce consistent results, aiding researchers in identifying the correct dose for future studies. Participants must be healthy adults who have never had whipworm and are willing to participate for about 7.5 months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel treatment.

Will I have to stop taking my current medications?

The trial requires that you do not use oral or parenteral corticosteroids, high-dose inhaled corticosteroids, or other immunosuppressive or cytotoxic drugs within 30 days before joining the study or during the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using Trichuris trichiura eggs in studies creates a controlled infection that remains safe for participants. These eggs develop into whipworms, which are typically more challenging to treat than similar parasites. Thus, the study aims to identify a safe dose.

In this study, researchers administer varying amounts of these eggs to healthy adults to determine a dose that is both safe and manageable. The goal is to ensure the infection does not cause harm. As an early-stage study, the primary aim is to assess whether the infection can be safely managed. Since this trial is being conducted in humans for the first time, observing participants' responses to the treatment is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for whipworm infections rely on antiparasitic medications like albendazole or mebendazole. But the Trichuris trichiura Egg Inoculum treatment works differently by using the parasite's own eggs to potentially boost the body's immune response against the infection. This approach is unique because it leverages a natural life cycle to potentially reduce infection rates. Researchers are excited about this treatment because it offers a novel mechanism of action and could provide an alternative for those who do not respond well to traditional drugs. Additionally, with different dosages being tested (150, 300, and 450 eggs), there's potential for a tailored approach to treatment effectiveness.

What evidence suggests that this trial's treatments could be effective for whipworm infection?

Research shows that whipworm, a type of parasite, can be difficult to treat, with some studies reporting cure rates as low as 28% to 36%. In this trial, participants will receive different doses of Trichuris trichiura Egg Inoculum—150, 300, or 450 eggs—to safely create a controlled infection. The goal is to determine the right number of eggs needed to ensure the infection remains consistent yet safe. This method can provide insights into the worm's behavior in the body and improve management strategies. Although this is an early study, it could lead to new treatments for whipworm infections. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral administration of Trichuris trichiura Egg Inoculum at varying doses

1 day

1 visit (in-person)

Dose Escalation and Monitoring

Participants are monitored for safety and tolerability, with dose escalation occurring no sooner than 16 weeks after the previous cohort

16 weeks per cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and fecal sample analysis

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Trichuris trichiura Egg Inoculum

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05706116

NCT05706116 | Controlled Human Infection Study of Orally ... The proposed study will be a feasibility study that will consist of administering different doses of the Trichuris trichiura Egg Inoculum to healthy adult ...

2. trialx.com trialx.com/clinical-trials/listings/299560/controlled-human-infection-study-of-orally-administered-trichuris-trichiura-eggs-in-naive-adults/

Controlled Human Infection Study of Orally Administered ... The proposed study will be a feasibility study that will consist of administering different doses of the Trichuris trichiura Egg Inoculum to ...

3. withpower.com withpower.com/trial/phase-1-infections-2-2023-f32cd

Trichuris trichiura Eggs for Whipworm Infection 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.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK507843/

Trichuris trichiura Infection - StatPearls - NCBI Bookshelf - NIH The whipworm tends to be more resistant to treatment than other helminths, with some studies listing cure rates as low as 28% to 36%. Whipworms can still be ...

5. gwdocs.org gwdocs.org/clinical-trials/controlled-human-infection-study-orally-administered-trichuris-trichiura-eggs-naive

A Controlled Human Infection Study of Orally Administered ... The goal of the study is to determine the optimal dose (i.e. number of whipworm eggs) that is safe, well-tolerated and results in consistent infection.

6. cdc.gov cdc.gov/dpdx/trichuriasis/index.html

DPDx - Trichuriasis T. trichiura eggs. Trichuris trichiura eggs are 50-55 micrometers by 20-25 micrometers. They are barrel-shaped, thick-shelled and possess a pair of polar “plugs ...