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Virus Therapy
Trichuris trichiura Eggs for Whipworm Infection
Phase 1
Waitlist Available
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12 through 26 post-chti
Awards & highlights
Study Summary
This trial tests the safety and effectiveness of an experimental product to cause infection with an intestinal nematode in adults to determine the optimal dosage.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort or symptoms related to a mild parasitic infection since participants will ingest whipworm eggs. The exact side effects are being studied as part of this research.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 12 through 26 post-chti
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12 through 26 post-chti
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events of Special Interest
Adverse events related to abnormal clinical safety laboratory parameter (absolute eosinophil count) values
Adverse events related to abnormal clinical safety laboratory parameter (hemoglobin concentration) values
+8 moreSecondary outcome measures
Fecal egg counts
Fecal egg detection
T. trichiura DNA in fecal samples
Other outcome measures
Cytokine concentrations of supernatants after stimulation of peripheral blood mononuclear cells (PBMCs) with T. trichiura antigen
Fecal microbiome
Serum cytokine concentrations
Trial Design
3Treatment groups
Experimental Treatment
Group I: Trichuris trichiura Egg Inoculum 450 eggsExperimental Treatment1 Intervention
450 Trichuris trichiura eggs
Group II: Trichuris trichiura Egg Inoculum 300 eggsExperimental Treatment1 Intervention
300 Trichuris trichiura eggs
Group III: Trichuris trichiura Egg Inoculum 150 eggsExperimental Treatment1 Intervention
150 Trichuris trichiura eggs
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
George Washington UniversityLead Sponsor
243 Previous Clinical Trials
453,229 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,277 Previous Clinical Trials
5,487,435 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to use birth control during the study.I have a significant health condition affecting my nerves, heart, lungs, liver, joints, immune system, blood sugar levels, or kidneys.My kidney function tests show my creatinine levels are high.I have a history of low iron levels or iron deficiency anemia.I am using or plan to use high-dose steroids or other immune-weakening drugs.I am between 18 and 45 years old.I have a weakened immune system due to an illness or treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Trichuris trichiura Egg Inoculum 150 eggs
- Group 2: Trichuris trichiura Egg Inoculum 300 eggs
- Group 3: Trichuris trichiura Egg Inoculum 450 eggs
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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