TrichuriasisPhase 2NCT04713787
A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults
A Phase 2 study testing Albendazole and Oxfendazole in people with Trichuriasis, run by Asociacion Benefica Prisma at 1 site in Peru.
Trial summary
This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trichuriasis
- What is being tested?
- Albendazole and Oxfendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 sitePeru
- Study dates
- 7 Sep 2024to 30 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-65 years, inclusive and weigh ≥45 kg.
- Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent.
- T. trichiura* is demonstrated in a stool sample obtained within 14 days before randomization and enrollment.
- The presence of A. lumbricoides, N. americanus, A. duodenalis, or other helminths will not be a cause for exclusion.
- Are willing to comply with the requirements of this protocol, particularly to provide four stool samples and two blood samples* over approximately 4- 6 weeks.
- An extra stool or blood sample might be required if the samples are not collected within the appropriate time frame or to follow up on abnormal laboratory tests.
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- Females must have a negative serum pregnancy test within 10 days or a negative urine pregnancy test 72 hours prior to the first study drug administration.*ª
- If a woman of child bearing potential is on an injectable form of contraception, a single serum pregnancy test at screening (Days -10 to -1) is acceptable. If the woman is not using an injectable form of contraception, a pregnancy test must be negative 72 hours prior to the first study drug administration.
- ª Pregnancy testing is not required for women of non-childbearing potential
- Female subjects of childbearing potential must be using effective contraception.* *Effective methods of contraception include: abstinence from sexual intercourse, monogamous relationship with a vasectomized partner, male condoms with spermicide, surgical sterility, intrauterine contraceptive device, oral or injectable contraceptives, diaphragm in combination with contraceptive cream or foam. Females aged >/=50 years who have had no menstrual periods for 1 year may be enrolled. Females must agree to continue effective contraception for approximately 28 days following the last study drug administration.
Who cannot join
- Has demonstrated a previous hypersensitivity reaction to oxfendazole or a related compound (e.g. albendazole, mebendazole).
- Has a diarrheal disease that would interfere with the evaluation of stool samples*.
- More than 6 stools per day or stools that are completely liquid.
- Has received an antihelminthic within 14 days before enrolment.
- Has received an investigational drug within 30 days before the screening visit or is scheduled to receive such a drug during this trial.
- Has a concomitant infection or another underlying disease that would compromise the safety, diagnosis, and evaluation of responses to the study drug.
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- Has a known history of renal dysfunction or plasma creatinine >/=1.5 times the upper limit of normal (ULN) for age.
- Has a known history of hepatic dysfunction or AST, ALT, total bilirubin >/=1.5 times the ULN.
- Has a hemoglobin that is less than 8 g/dL.
- Is a female who is pregnant, lactating, or planning a pregnancy during this trial (up to days 28 after the last scheduled dose).
- Has previously been enrolled in this trial.
- Has any condition that would, in the investigator's opinion, interfere with this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peru1 site, 1 recruiting
- Recruiting
Policlinico Asociacion Benefica Prisma
Santa Clara, Maynas
Maribel Paredes Olortegui, BS, MPH, +65 234250, mparedeso@prisma.org.pe
Margaret Kosek, MD, 434-982-6768, mnk2n@virginia.edu
About this study
Official title: A Phase 2, Partially-Blinded, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole for the Treatment of Trichuris Trichiura Infection in Adults
This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. 249 subjects will be randomized in a 1:1:1 ratio to one of three dose-groups to receive a single dose of oxfendazole 400 mg or 800 mg, or a single dose of albendazole 400 mg. The study team members and study subjects will not be blinded to the dose group. However, the laboratory assessors evaluating the stool samples will be blinded. Subjects will be recruited in Iquitos, Peru, and surrounding villages where there is a high prevalence of T. trichiura infection. Subjects will be solicited through town hall meetings and local clinics and through recommendations from local care providers. A two-stage screening process will be utilized. If subjects are found on the screening stool exam to have only a stool parasite other than T. trichuria or if the subject chooses not to participate in the study, the subject will be referred to a local health provider. If stool analysis performed at the end of the study period demonstrates stool parasites, the subjects will be contacted and referred to their local health provider where they will receive standard of care treatment. The primary objective is to assess the cure rate of different dose regimens of oxfendazole vs. albendazole in the treatment of T. trichiura infections using the Kato-Katz stool examination method.
Read the detailed description
This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. 249 subjects will be randomized in a 1:1:1 ratio to one of three dose-groups to receive a single dose of oxfendazole 400 mg or 800 mg, or a single dose of albendazole 400 mg. Water and a snack will be provided to aid in ingestion of the study product and a study team member will observe the ingestion of study product. The study team members and study subjects will not be blinded to the dose group. However, the laboratory assessors evaluating the stool samples will be blinded. Subjects will be recruited in Iquitos, Peru, and surrounding villages where there is a high prevalence of T. trichiura infection. Subjects will be solicited through town hall meetings and local clinics and through recommendations from local care providers. A two-stage screening process will be utilized. If subjects are found on the screening stool exam to have only a stool parasite other than T. trichuria or if the subject chooses not to participate in the study, the subject will be referred to a local health provider. If stool analysis performed at the end of the study period demonstrates stool parasites, the subjects will be contacted and referred to their local health provider where they will receive standard of care treatment. The primary objective is to assess the cure rate of different dose regimens of oxfendazole vs. albendazole in the treatment of T. trichiura infections using the Kato-Katz stool examination method. The secondary objectives are to: 1) assess the cure rate of different dose regimens of oxfendazole vs albendazole in the treatment of T. trichiura infections using the stool concentration examination method, 2) assess the clinical response compared to baseline, as shown by reduction in T. trichiura egg counts using the Kato-Katz stool examination method, 3) assess the clinical response compared to baseline, as shown by reduction in T. trichiura egg counts using the stool concentration method, 4) assess the proportion of subjects with moderate or heavy infection before treatment who had no infection or only light infection after treatment using the Kato-Katz stool examination method, 5) assess the proportion of subjects with moderate or heavy infection before treatment who had no infection or only light infection after treatment using the stool concentration examination method, 6) establish the spectrum of activity of oxfendazole against other intestinal helminths using the Kato-Katz stool examination method, 7) establish the spectrum of activity of oxfendazole against other intestinal helminths using the stool concentration examination method, 8) assess the tolerability of each oxfendazole dose group compared to the albendazole dose group, and 9) assess the safety in subjects treated with oxfendazole.
- Conditions
- Trichuriasis
- Being tested
- Albendazole, Oxfendazole
- Keywords
- Adults, Albendazole, Comparative Study, Efficacy, Oxfendazole, Phase 2, Trichuris trichiura
- Medical subject headings
- Trichuriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Albendazole, 5-(prophylthio)-2-benzimidazole carbamate, is a broad-spectrum benzimidazole antihelminthic drug. It is provided as a white to off-white, circular, film-coated tablet with a slightly raised pentagonal projection on either side. This trial will use the 400 mg tablet formulation.
OxfendazoleDrug
The active pharmaceutical ingredient is methyl-5 (6)-phenylsulfiyl-2-benzimidazole carbamate, which is a broad-spectrum benzimidazole antihelminthic. Oxfendazole is the sulphoxide metabolite of fenbendazole.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 400 mg (4 capsules of 100 mg) of Oxfendazole administered orally as a single dose on Day 1. N=83. Receives: Drug: Oxfendazole |
| Group B | Experimental | 800 mg (8 capsules of 100 mg) of Oxfendazole administered orally as a single dose on Day 1. N=83. Receives: Drug: Oxfendazole |
| Group C | Active comparator | 400 mg (1 tablet of 400 mg) of Albendazole administered orally as a single dose on Day 1. N=83. Receives: Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infection cures (Clinical Cure) as shown by absence of Trichuris trichiura eggs using the Kato-Katz stool examination method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Measured: Day 18 through Day 23
Secondary outcomes (12)
Change from baseline in eggs per gram of stool for helminths other than Trichuris trichiura using the Kato Katz examination method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Measured: Day 18 through Day 23
Change from baseline in eggs per gram of stool for helminths other than Trichuris trichiura using the stool concentration examination method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Measured: Day 18 through Day 23
Change from baseline in eggs per gram of stool using the Kato-Katz stool examination method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Measured: Day 18 through Day 23
Change from baseline in eggs per gram of stool using the stool concentration method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Measured: Day 18 through Day 23
Egg reduction rate, relative to egg counts at baseline, measured using the Kato-Katz stool examination method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from egg counts (eggs per gram) from two stool samples (each evaluated in duplicate).
Measured: Day 18 through Day 23
Egg reduction rate, relative to egg counts at baseline, using the stool concentration method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from egg counts (eggs per gram) from two stool samples (each evaluated in duplicate).
Measured: Day 18 through Day 23
Number of infection cures (Clinical Cure) as shown by absence of Trichuris trichiura eggs using the stool concentration method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Measured: Day 18 through Day 23
Proportion of abnormal laboratory tests
As measured in each oxfendazole dose group compared to the albendazole dose group. Abnormal laboratory tests include hemoglobin (Hgb), white blood cells (WBC), neutrophil and eosinophil counts, platelet counts, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase, and creatinine.
Measured: Day 1 through Day 23
Proportion of solicited clinical reactogenicity events
As measured in each oxfendazole dose group compared to the albendazole dose group. Solicited clinical reactogenicity events including nausea, vomiting, abdominal pain, diarrhea, and anorexia.
Measured: Day 1 through Day 23
Proportion of subjects in each dose group with moderate or heavy infection who had no infection or only light infection after treatment based on WHO classes of intensity, measured using the Kato-Katz tool examination method
According to WHO thresholds, infections of 1-999 eggs per gram (epg) are classified as light intensity infections, 1,000-9,999 epg are classified as moderate, and >/= 10,000 epg are classified as heavy.
Classification at baseline will be based on the screening stool sample, and classification post-treatment will be based on two stool samples each oxfendazole dose group compared to the albendazole dose group.
Measured: Day 18 through Day 23
Proportion of unsolicited adverse events (AEs)
As measured in each oxfendazole dose group compared to the albendazole dose group.
Measured: Day 1 through Day 23
Serious adverse events (SAEs) related to the study product
As measured in each oxfendazole dose group compared to the albendazole dose group.
Measured: Day 1 through Day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start7 Sep 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrichuriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociacion Benefica Prisma
- Sponsor type
- University, hospital or other
- Collaborators
- Policlinico Asociacion Benefica PRISMA-Laboratorio Satelite IQTLAB, National Institutes of Health (NIH), University of Iowa, University of Virginia
- Responsible party
- Sponsor
- Investigators
- Maribel Paredes Olortegui, MPH, Study director, AB Prisma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713787
- Sponsor's protocol ID
- 18-0004
- Other IDs
- HHSN272201300020I, IND158335
- Status last verified
- Jul 2026
- First submitted
- 14 Jan 2021
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Partially-Blinded, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole for the Treatment of Trichuris Trichiura Infection in Adults
- ClinicalTrials.gov ID
- NCT04713787
- Acronym / sponsor ID
- 18-0004
- Conditions
- Trichuriasis
- Keywords
- Adults, Albendazole, Comparative Study, Efficacy, Oxfendazole, Phase 2, Trichuris trichiura
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Asociacion Benefica PrismaUniversity, hospital or other
- Collaborators
- Policlinico Asociacion Benefica PRISMA-Laboratorio Satelite IQTLAB, National Institutes of Health (NIH), University of Iowa, University of Virginia
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. 249 subjects will be randomized in a 1:1:1 ratio to one of three dose-groups to receive a single dose of oxfendazole 400 mg or 800 mg, or a single dose of albendazole 400 mg. The study team members and study subjects will not be blinded to the dose group. However, the laboratory assessors evaluating the stool samples will be blinded. Subjects will be recruited in Iquitos, Peru, and surrounding villages where there is a high prevalence of T. trichiura infection. Subjects will be solicited through town hall meetings and local clinics and through recommendations from local care providers. A two-stage screening process will be utilized. If subjects are found on the screening stool exam to have only a stool parasite other than T. trichuria or if the subject chooses not to participate in the study, the subject will be referred to a local health provider. If stool analysis performed at the end of the study period demonstrates stool parasites, the subjects will be contacted and referred to their local health provider where they will receive standard of care treatment. The primary objective is to assess the cure rate of different dose regimens of oxfendazole vs. albendazole in the treatment of T. trichiura infections using the Kato-Katz stool examination method.
Detailed description
This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. 249 subjects will be randomized in a 1:1:1 ratio to one of three dose-groups to receive a single dose of oxfendazole 400 mg or 800 mg, or a single dose of albendazole 400 mg. Water and a snack will be provided to aid in ingestion of the study product and a study team member will observe the ingestion of study product. The study team members and study subjects will not be blinded to the dose group. However, the laboratory assessors evaluating the stool samples will be blinded. Subjects will be recruited in Iquitos, Peru, and surrounding villages where there is a high prevalence of T. trichiura infection. Subjects will be solicited through town hall meetings and local clinics and through recommendations from local care providers. A two-stage screening process will be utilized. If subjects are found on the screening stool exam to have only a stool parasite other than T. trichuria or if the subject chooses not to participate in the study, the subject will be referred to a local health provider. If stool analysis performed at the end of the study period demonstrates stool parasites, the subjects will be contacted and referred to their local health provider where they will receive standard of care treatment. The primary objective is to assess the cure rate of different dose regimens of oxfendazole vs. albendazole in the treatment of T. trichiura infections using the Kato-Katz stool examination method. The secondary objectives are to: 1) assess the cure rate of different dose regimens of oxfendazole vs albendazole in the treatment of T. trichiura infections using the stool concentration examination method, 2) assess the clinical response compared to baseline, as shown by reduction in T. trichiura egg counts using the Kato-Katz stool examination method, 3) assess the clinical response compared to baseline, as shown by reduction in T. trichiura egg counts using the stool concentration method, 4) assess the proportion of subjects with moderate or heavy infection before treatment who had no infection or only light infection after treatment using the Kato-Katz stool examination method, 5) assess the proportion of subjects with moderate or heavy infection before treatment who had no infection or only light infection after treatment using the stool concentration examination method, 6) establish the spectrum of activity of oxfendazole against other intestinal helminths using the Kato-Katz stool examination method, 7) establish the spectrum of activity of oxfendazole against other intestinal helminths using the stool concentration examination method, 8) assess the tolerability of each oxfendazole dose group compared to the albendazole dose group, and 9) assess the safety in subjects treated with oxfendazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Oxfendazole400 mg (4 capsules of 100 mg) of Oxfendazole administered orally as a single dose on Day 1. N=83. |
| Group B | Experimental | Drug: Oxfendazole800 mg (8 capsules of 100 mg) of Oxfendazole administered orally as a single dose on Day 1. N=83. |
| Group C | Active comparator | Drug: Albendazole400 mg (1 tablet of 400 mg) of Albendazole administered orally as a single dose on Day 1. N=83. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female aged 18-65 years, inclusive and weigh ≥45 kg.
- Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent.
- T. trichiura* is demonstrated in a stool sample obtained within 14 days before randomization and enrollment.
- The presence of A. lumbricoides, N. americanus, A. duodenalis, or other helminths will not be a cause for exclusion.
- Are willing to comply with the requirements of this protocol, particularly to provide four stool samples and two blood samples* over approximately 4- 6 weeks.
Key exclusion criteria (12 listed)
- Has demonstrated a previous hypersensitivity reaction to oxfendazole or a related compound (e.g. albendazole, mebendazole).
- Has a diarrheal disease that would interfere with the evaluation of stool samples*.
- Has received an antihelminthic within 14 days before enrolment.
- Has received an investigational drug within 30 days before the screening visit or is scheduled to receive such a drug during this trial.
- Has a concomitant infection or another underlying disease that would compromise the safety, diagnosis, and evaluation of responses to the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbendazoleAlbendazole, 5-(prophylthio)-2-benzimidazole carbamate, is a broad-spectrum benzimidazole antihelminthic drug. It is provided as a white to off-white, circular, film-coated tablet with a slightly raised pentagonal projection on either side. This trial will use the 400 mg tablet formulation. | Drug | Group C |
| OxfendazoleThe active pharmaceutical ingredient is methyl-5 (6)-phenylsulfiyl-2-benzimidazole carbamate, which is a broad-spectrum benzimidazole antihelminthic. Oxfendazole is the sulphoxide metabolite of fenbendazole. | Drug | Group A, Group B |
Primary outcome
Number of infection cures (Clinical Cure) as shown by absence of Trichuris trichiura eggs using the Kato-Katz stool examination method
Time frame: Day 18 through Day 23
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
12 secondary outcomes
Change from baseline in eggs per gram of stool for helminths other than Trichuris trichiura using the Kato Katz examination method
Time frame: Day 18 through Day 23
Change from baseline in eggs per gram of stool for helminths other than Trichuris trichiura using the stool concentration examination method
Time frame: Day 18 through Day 23
Change from baseline in eggs per gram of stool using the Kato-Katz stool examination method
Time frame: Day 18 through Day 23
Change from baseline in eggs per gram of stool using the stool concentration method
Time frame: Day 18 through Day 23
Egg reduction rate, relative to egg counts at baseline, measured using the Kato-Katz stool examination method
Time frame: Day 18 through Day 23
Egg reduction rate, relative to egg counts at baseline, using the stool concentration method
Time frame: Day 18 through Day 23
Number of infection cures (Clinical Cure) as shown by absence of Trichuris trichiura eggs using the stool concentration method
Time frame: Day 18 through Day 23
Proportion of abnormal laboratory tests
Time frame: Day 1 through Day 23
Proportion of solicited clinical reactogenicity events
Time frame: Day 1 through Day 23
Proportion of subjects in each dose group with moderate or heavy infection who had no infection or only light infection after treatment based on WHO classes of intensity, measured using the Kato-Katz tool examination method
Time frame: Day 18 through Day 23
Proportion of unsolicited adverse events (AEs)
Time frame: Day 1 through Day 23
Serious adverse events (SAEs) related to the study product
Time frame: Day 1 through Day 23
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maribel Paredes Olortegui, MPH study director
AB Prisma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albendazole and Oxfendazole in people with Trichuriasis, run by Asociacion Benefica Prisma at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia L. Winokur (13193844590, patricia-winokur@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infection cures (Clinical Cure) as shown by absence of Trichuris trichiura eggs using the Kato-Katz stool examination method (time frame: Day 18 through Day 23). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.