[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trichuriasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trichuriasis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100641330","phase-3-combination-therapies-for-trichuris-trichiura-infection-in-schoolchildren-in-honduras-100641330",false,"NCT07661316","Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras","Randomized, Open-Label, Assessor-Blinded Clinical Trial of Combination Therapies Versus Standard Treatment for Trichuris Trichiura Infection in Schoolchildren in La Moskitia, Honduras","AIM-T","Inclusion Criteria:\n\n* Trichuris trichiura infection documented by quantitative real-time PCR (qPCR) performed within 30 days prior to randomization.\n* Age 6 to 15 years inclusive.\n* Written informed consent provided by a parent or legal guardian. Assent provided by children aged 9 years or older, according to local ethical requirements.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to albendazole or ivermectin.\n* Receipt of an anthelmintic treatment (albendazole, mebendazole, or ivermectin) within 3 months prior to enrollment.\n* Participation in another clinical trial within 3 months prior to enrollment.\n* Severe comorbidity at the investigator's discretion (e.g., diarrhea, tuberculosis, or malaria).\n* Body weight \\\u003C15 kg.\n* Positive pregnancy test or refusal to undergo pregnancy testing in post-menarcheal girls and female adolescents of childbearing potential.","ALL","6 Years","15 Years",{"count":21,"type":22},368,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this Phase III clinical trial is to evaluate the efficacy, safety, and acceptability of different treatment regimens for Trichuris trichiura infection in schoolchildren aged 6 to 15 years living in La Moskitia, Honduras, an area with a high burden of soil-transmitted helminth infections.\n\nThe main questions it aims to answer are:\n\n* Are combination treatments of albendazole and ivermectin more effective than albendazole alone for treating Trichuris trichiura infection?\n* Does a fixed-dose combination (FDC) of albendazole and ivermectin achieve cure rates comparable to co-administration of the two drugs?\n* How effective are the different treatment regimens against other soil-transmitted helminths, including Strongyloides stercoralis?\n* What adverse events occur following treatment with the different regimens?\n* How acceptable are the different treatment regimens to children and their caregivers?\n\nResearchers will compare four treatment groups: placebo, albendazole alone, albendazole plus ivermectin, and a fixed-dose combination of albendazole plus ivermectin.\n\nParticipants will:\n\n* Be randomly assigned to one of the four treatment groups.\n* Receive a single dose of the assigned treatment.\n* Provide stool samples before treatment and approximately 21 days after treatment.\n* Undergo laboratory testing using quantitative real-time PCR (qPCR) to detect and quantify helminth infections.\n* Be monitored for adverse events after treatment.\n* Complete acceptability assessments together with their caregivers.\n\nThe study will provide evidence on the efficacy, safety, and acceptability of a fixed-dose combination of albendazole and ivermectin and its potential use as a simplified treatment strategy for the control of soil-transmitted helminth infections in endemic settings.",[28,29,30,31,32],"Trichuriasis","Strongyloidiasis","Ascariasis","Hookworm Infection","Soil-Transmitted Helminthiasis",[34,35,36,37,38,39,40],"HONDURAS","TRICHURIS TRICHIURA","IVERMECTIN","MOSKITIA","SCHOOL AGE CHILDREN","SOIL TRANSMITTED HELMINTHIASIS","ALBENDAZOLE AND IVERMECTIN FIXED DOSE COMBINATION","NOT_YET_RECRUITING","2026-06-18",{"date":44,"type":45},"2026-06-23","ACTUAL",{"date":47,"type":22},"2026-11-01",{"date":49,"type":22},"2027-05-31",{"name":51,"class":52},"Mundo Sano Foundation","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100493512","phase-1-controlled-human-infection-study-of-orally-administered-trichuris-trichiura-eggs-in-nave-adults-100493512","NCT05706116","Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults","A Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults","Inclusion Criteria:\n\n1. Males or females between 18 and 45 years, inclusive.\n2. Good general health as determined by means of the screening procedures.\n3. Available for the duration of the trial (approximately 7.5 months).\n4. Willingness to participate in the study as evidenced by signing the informed consent document.\n5. Ability to sign and understand the informed consent document.\n\nExclusion Criteria:\n\n1. Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).\n2. Participant unwilling to use reliable contraception methods while participating in the study (if female of reproductive potential who is engaging in sexual activity that could lead to pregnancy); being of reproductive potential is defined as not being surgically sterile, abstinent from intercourse with a male partner, in a monogamous relationship with a vasectomized partner, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile.\n3. Currently lactating and breast-feeding (if female).\n4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and\u002For laboratory studies.\n5. Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits\u002Fprocedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide).\n6. Known or suspected immunodeficiency or immunosuppression as a result of an underlying illness or treatment.\n7. Laboratory evidence of liver disease (alanine aminotransferase \\[ALT\\] greater than 1.25-times the upper reference limit).\n8. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit).\n9. Laboratory evidence of hematologic disease (hemoglobin \\\u003C11.1 g\u002Fdl \\[females\\] or \\\u003C12.5 g\u002Fdl \\[males\\]; absolute leukocyte count \\\u003C3.4 or \\>11.0 x 103\u002Fmm3; absolute eosinophil count \\>0.6 x 103\u002Fmm3 or platelet count \\\u003C125 x 103\u002Fmm3).\n10. Positive fecal occult blood test.\n11. Infection with a pathogenic intestinal helminth as determined by stool examination for ova and parasites.\n12. History of iron deficiency anemia or laboratory evidence of iron deficiency (serum ferritin concentration below the lower reference limit).\n13. 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.\n14. Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 24 months.\n15. Positive ELISA for hepatitis B surface antigen (HBsAg).\n16. Positive confirmatory test for HIV infection.\n17. Positive confirmatory test for hepatitis C virus (HCV) infection.\n18. Using or intends to continue using oral or parenteral corticosteroids, high-dose inhaled corticosteroids (\\>800 μg\u002Fday of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs within 30 days of the volunteer's expected enrollment in this study or planned use during the study.\n19. Known allergy to albendazole.\n20. History of previous infection with T. trichiura or continuous residence for more than 6 months in a T. trichiura-endemic area.\n21. Inability to speak English.\n22. Current\u002Fplanned simultaneous participation in another study of an investigational agent or device for the duration of their study participation.",true,"18 Years","45 Years",{"count":65,"type":22},18,[67],"PHASE1","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.",[70,28,71],"Whipworm","Controlled Human Infection","RECRUITING","2026-06-03",{"date":75,"type":45},"2026-06-04",{"date":77,"type":45},"2025-09-10",{"date":79,"type":22},"2028-04-30",{"name":81,"class":52},"George Washington University",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":53},"100417292","phase-2-a-safety-and-efficacy-study-of-different-doses-of-oxfendazole-compared-to-a-single-dose-of-albendazole-to-treat-trichuris-trichiura-infection-in-adults-100417292","NCT04713787","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, 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","Inclusion Criteria:\n\n1. Male or female aged 18-65 years, inclusive and weigh ≥45 kg.\n2. Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent.\n3. T. trichiura\\* is demonstrated in a stool sample obtained within 14 days before randomization and enrollment.\n\n   \\*The presence of A. lumbricoides, N. americanus, A. duodenalis, or other helminths will not be a cause for exclusion.\n4. 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.\n\n   \\*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.\n5. 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\n\n   \\*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.\n\n   ª Pregnancy testing is not required for women of non-childbearing potential\n6. 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 \\>\u002F=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.\n\nExclusion Criteria:\n\n1. Has demonstrated a previous hypersensitivity reaction to oxfendazole or a related compound (e.g. albendazole, mebendazole).\n2. Has a diarrheal disease that would interfere with the evaluation of stool samples\\*.\n\n   \\* More than 6 stools per day or stools that are completely liquid.\n3. Has received an antihelminthic within 14 days before enrolment.\n4. Has received an investigational drug within 30 days before the screening visit or is scheduled to receive such a drug during this trial.\n5. Has a concomitant infection or another underlying disease that would compromise the safety, diagnosis, and evaluation of responses to the study drug.\n6. Has a known history of renal dysfunction or plasma creatinine \\>\u002F=1.5 times the upper limit of normal (ULN) for age.\n7. Has a known history of hepatic dysfunction or AST, ALT, total bilirubin \\>\u002F=1.5 times the ULN.\n8. Has a hemoglobin that is less than 8 g\u002FdL.\n9. Is a female who is pregnant, lactating, or planning a pregnancy during this trial (up to days 28 after the last scheduled dose).\n10. Has previously been enrolled in this trial.\n11. Has any condition that would, in the investigator's opinion, interfere with this trial.","65 Years",{"count":92,"type":22},249,[94],"PHASE2","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.",[28],[98,99,100,101,102,103,104],"Adults","Albendazole","Comparative Study","Efficacy","Oxfendazole","Phase 2","Trichuris trichiura","2025-07-25",{"date":107,"type":45},"2025-07-29",{"date":109,"type":45},"2024-09-07",{"date":111,"type":22},"2026-06-30",{"name":113,"class":52},"Asociacion Benefica Prisma"]