Trichuris trichiura Eggs for Whipworm Infection

Recruiting at 1 trial location

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

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.

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 it safe to use Trichuris trichiura eggs for whipworm infection in humans?

There is no established safe dose for using Trichuris suis eggs (a related species) in humans, and studies have shown that they can cause adverse stomach and intestinal reactions. The safety of using these eggs as a treatment has not been confirmed. ^{1 2 3 4 5}

What makes the Trichuris trichiura Egg Inoculum treatment unique for whipworm infection?

The Trichuris trichiura Egg Inoculum treatment is unique because it involves using the eggs of the whipworm itself to treat the infection, which is different from standard drug treatments that typically use medications to kill the worms. This approach may help the body build a natural tolerance or immune response to the parasite. ^{6 7 8 9 10}

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

Timeline

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

Treatment Details

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.

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+

References

1. Puerto Rico pubmed.ncbi.nlm.nih.gov

Abnormal Trichuris trichiura eggs detected during an epidemiological survey. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Bacteria-induced egg hatching differs for Trichuris muris and Trichuris suis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Safety of viable embryonated eggs of the whipworm Trichuris suis as a novel food pursuant to Regulation (EU) 2015/2283. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mebendazole treatment persistently alters the size profile and morphology of Trichuris trichiura eggs. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Advances in vaccine development for human trichuriasis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Shigella and enteroinvasive Escherichia coli infections in households of children with dysentery in Bangkok. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The role of Shigella spp., enteroinvasive Escherichia coli, and other enteropathogens as causes of childhood dysentery in Thailand. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Evolution of antimicrobial resistance in enteroaggregative Escherichia coli and enterotoxigenic Escherichia coli causing traveller's diarrhoea. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Development of a duplex real-time PCR for differentiation between E. coli and Shigella spp. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Characterization of enterotoxigenic Escherichia coli strains in patients with travelers' diarrhea acquired in Guadalajara, Mexico, 1992-1997. [2006]