[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"shigella\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:shigella":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100626268","phase-2-the-impact-of-shigellosis-and-recommended-treatment-in-children-100626268",false,"NCT07433426","The Impact of Shigellosis and Recommended Treatment in Children","TrtNDSD","Inclusion Criteria:\n\n* Patients \\>6 and ≤59 months of age seeking care in the study hospitals\n* Patients residing within the study catchment area\n* Present with watery diarrhea and positive for Shigella by RLDT\n* Willing to be available for sample and data collection during the follow up visits\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant's parent\u002Fguardian to give written informed consent or comply with study protocol\n* Diarrhea started more than 96 hours before enrollment\n* Antibiotics related to shigellosis treatment (including the investigational drug azithromycin) taken in the past 5 days\n* More than 2 doses of antidiarrheal drugs taken in the past 24 hours\n* History of allergy to Azithromycin\n* Presence of visible blood in stool\n* Children with severe acute malnutrition (below -3z scores of the median WHO growth standards).\n* History of congenital heart diseases, known gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease, inherited or acquired immune system deficiency rendering the patient immunocompromised, including chronic\u002Flong-term steroid treatment or other immunosuppressive treatment\n* Fever over 39°C (102°F) with other complications that require antibiotic treatment\n* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study","ALL","6 Months","59 Months",{"count":20,"type":21},700,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to evaluate whether antibiotic treatment of non-dysentery Shigella associated watery diarrhea (NDSD) cases improves clinical outcomes and growth in children.\n\nChildren with NDSD seeking care for diarrhea at the study hospitals in Bangladesh and Zambia will be enrolled and randomized to receive Azithromycin or placebo (a look-alike substance that contains no drug). Enrolled children will be followed for three months with household visits.\n\nThe investigators will determine whether antibiotic treatment of NDSD reduces the duration of diarrhea and time to microbiological cure (shedding of Shigella in stool), and whether it improves growth in children compared with the placebo group.",[27,28,29],"Diarrhea Infectious","Shigella","Growth & Development",[31,32,33,34,35,36,37],"shigella","children","randomized clinical trial","weight for age","growth outcomes","Azithromycin","Diarrhea","RECRUITING","2026-03-27",{"date":41,"type":42},"2026-03-30","ACTUAL",{"date":44,"type":42},"2026-03-18",{"date":46,"type":21},"2030-08",{"name":48,"class":49},"Johns Hopkins Bloomberg School of Public Health","OTHER",4,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100608774","phase-1-first-in-human-dose-escalation-study-evaluating-the-safety-and-immunogenicity-of-ivts-shigella-04-vaccine-in-healthy-young-adults-100608774","NCT07205926","First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults","First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety and Immunogenicity of IVT Shigella-04 in Healthy Young Adults","Inclusion Criteria\n\nParticipants who meet all the following criteria may be included in the study:\n\n1. Age 18 to 49 years at the time of Dose 1\n2. Good general health status, as determined by medical history, physical examination, safety laboratory tests, ECG, vital signs, and clinical judgment\n3. BMI ≥ 18.0 kg\u002Fm2 and ≤ 32.0 kg\u002Fm2\n4. Negative alcohol breath test and urine drug screen results at Screening and on Day 1\n5. All women: negative serum pregnancy test at Screening and negative urine pregnancy on Day 1\n6. Women of childbearing potential (see definition in Section 6.6.1): willingness to use a highly effective form of contraception (see list in Section 6.6.1) through 28 days after the last IP dose\n7. Willingness to attend all protocol visits and to have all protocol-required procedures\n8. Provision of written informed consent\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Currently lactating\n2. History of shigellosis or participation in a Shigella challenge study\n3. History of bloody diarrhea without alternative diagnosis\n4. History of inflammatory bowel disease\n5. History of anaphylaxis or angioedema\n6. History of malignancy, excluding nonmelanoma skin cancer, cervical carcinoma in situ, and malignancies considered cured \\> 5 years prior to Day 1\n7. History of diabetes mellitus (Individuals with diet-controlled diabetes or history of gestational diabetes are eligible if screening blood glucose is normal and there has been no requirement for antidiabetic medication in the last year.)\n8. Known hypersensitivity to any of the ingredients in IVT Shigella-04\n9. Inadequate venous access for repeated phlebotomy\n10. Any screening laboratory test result outside the normal range and grade ≥ 2 according to the FDA's toxicity grading scale for vaccine trials in healthy adults and adolescents; (Elevated creatine kinase and isolated elevations of bilirubin may be Grade 2 if hepatic transaminases are normal and the Investigator attributes the abnormality to exercise or Gilbert's syndrome. Potential cases of benign ethnic neutropenia should be discussed with the Medical Monitor)\n11. Positive serologic test for human HIV-1 or HIV-2 antibody, hepatitis B surface antigen, or hepatitis C antibody\n12. Immunodeficiency or chronic administration (\\> 14 consecutive days) of immunosuppressant or other immune-modifying drugs (see details in Section 6.6.2), including systemic glucocorticoids, within 6 months before Day 1 (topical, intra-articular, or inhaled glucocorticoids permitted)\n13. Previous receipt of a licensed or investigational Shigella vaccine\n14. Planned receipt of any other vaccine through Day 57\n15. Receipt of blood transfusion or blood product within 6 months before Day 1 or planned receipt through Day 57\n16. Receipt of any other IP within 90 days before Day 1 or planned receipt through the end of the study\n17. Planned elective hospitalization or surgical procedure through the end of the study\n18. Occupational exposure to Shigella (eg, laboratory work)\n19. Residence ≥ 6 months in a low-income or lower-middle-income country as defined by the World Bank (https:\u002F\u002Fdatatopics.worldbank.org\u002Fworld-development-indicators\u002Fthe-world-by-income-and-region.html)\n20. Employee of Inventprise, vendors, or research sites associated with the study\n21. Any medical, psychiatric, substance use, or social condition that, in the judgment of the Investigator, may pose a risk to the participant or interfere with protocol adherence, assessment of study objectives, or ability to provide informed consent\n\nTemporary Delay Criteria\n\nAdministration of IVT Shigella-04\u002Fplacebo will be delayed for any participant who meets any of the following criteria:\n\n1. Receipt of any vaccine in the past 7 days\n2. Febrile illness (eg, oral temperature ≥ 38.0°C), diarrhea, or other acute illness in the past 48 hours\n3. Presence of any other sign, symptom, or medication use that could inhibit the proper vaccine administration of IVT Shigella-04\u002Fplacebo or interpretation of diary data\n\nThese criteria are temporary or self-limiting, and IVT Shigella-04\u002Fplacebo may be administered once the time frame has elapsed\u002Fthe condition has resolved.",true,"18 Years","49 Years",{"count":62,"type":21},60,[64],"PHASE1","Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults",[28,37],"2025-11-17",{"date":69,"type":42},"2025-11-19",{"date":71,"type":42},"2025-10-09",{"date":73,"type":21},"2026-08-21",{"name":75,"class":76},"Inventprise Inc.","INDUSTRY",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":77},"100596721","phase-2-safety-and-efficacy-study-of-shigetec-a-live-attenuated-oral-combination-vaccine-to-prevent-shigella-and-etec-disease-delivered-to-healthy-adults-ages-18-to-50-years-old-100596721","NCT07049159","Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old","A Two-stage, Phase 2b, Randomized, Double-blind, Placebo-controlled Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old","Inclusion Criteria for stage 1:\n\n1. Generally healthy non-pregnant, non-nursing adults aged 18 to 50 years.\n2. Who are determined by medical history, physical examination, laboratory testing, and clinical judgment to be eligible for this study.\n3. Who provide written informed consent after the nature of the study had been explained.\n4. Who are available for the duration of the trial (from enrollment to study completion).\n5. Who are able to understand and are willing to comply with all study requirements, and willing to follow the instructions of the study staff and complete a comprehension test.\n6. Who have a body mass index (BMI) ≥19 and \\\u003C40 kg\u002Fm2.\n7. Participants of child-bearing potential must agree to avoid pregnancy throughout the study until 29 days following the challenge dose by use of an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable if it is a lifestyle choice (not just to participate in the study). If the participant is abstinent at the time of signing the informed consent and becomes sexually active, they must agree to use contraception as described. Participants who are unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).\n8. Who are willing to not smoking during inpatient stay.\n9. Who are willing to refrain from participating in other studies of investigational products until completion of the last study visit.\n\nExclusion Criteria for stage 1:\n\n1. Participants who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period.\n2. Presence of a significant medical or psychiatric condition which in the opinion of the Investigator precludes participation in the study.\n3. Clinically significant abnormalities in screening hematology or serum chemistry, defined as \\> grade 1 abnormality of serum potassium, alanine aminotransferase (ALT) or creatinine, hemoglobin, white blood cell count (WBC), or neutrophil count.\n4. Who have received any blood products, including immunoglobulin, in the period from 6 months prior to vaccination or are anticipated to receive such products through to the conclusion of the study and have not donated blood within 30 days and agree not to donate blood until 1 year after challenge.\n5. Who are receiving systemic antibiotics, completed antibiotic therapy, or receiving probiotics, prebiotics or synbiotics in previous 7 days before vaccination, or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing with vaccine.\n6. Who have an immunosuppressive condition or IgA deficiency (serum IgA \\\u003C7 mg\u002Fdl or limit of detection of assay) or evidence of impaired immune function, either congenital, acquired, or iatrogenic.\n7. Who have or are participating in or have concluded participation in a clinical research study in the last 30 days or have not cleared the experimental product prior to vaccination.\n8. Received a live vaccine within 30 days before scheduled receipt of IP; or an inactivated vaccine within 14 days before scheduled receipt of IP.\n9. Who have a chronic non-gastrointestinal medical condition (e.g., hypertension, hyperlipidemia) that is not well controlled with medication.\n10. Who have a significant history of or current diagnosis of diseases of the gastrointestinal tract (i.e., liver, gallbladder, bowel, or stomach), including inflammatory bowel disease, are on medication for such disease, or have had significant bowel surgery (with the exclusion of hernia repair, cholecystectomy, or appendectomy).\n11. Presence of HIV antibody, HBsAg, or HCV antibody (if confirmed positive by HepC confirmatory test, i.e., recombinant immunoblot assay, PCR).\n12. Who have a personal or family history of reactive arthritis or are HLA B-27 positive and therefore at risk for developing reactive arthritis following naturally acquired bacterial gastrointestinal infection.\n13. Who work as a food handler or in direct patient, child day care, or elder care.\n14. Who have immunocompromised household member.\n15. Who have a child under the age of 2 living in their household.\n16. Who have had a culture proven Shigella or ETEC infection within the last 5 years.\n17. Who have a serum IgG titer \\>2500 to Shigella flexneri 2a.\n18. Who have regularly abnormal stool patterns (fewer than 3 stools per week or more than 3 stools per day) or loose or liquid stools.\n19. Who regularly use antidiarrheals, laxatives or any agents modulating gastric pH (regular defined as at least weekly).\n20. Who have known allergy to 2 of the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole or ampicillin.\n21. Who have known intolerance or allergy against polyethylene glycol (PEG); or corn starch.\n22. Who have known intolerance or allergy to soy.\n23. Who have personal history of or first-degree family member with an autoimmune disease.\n24. Use any medication known to affect the immune function (e.g., systemic steroids) within 30 days preceding the first vaccination or planned use during the entire study period.\n25. Who received an investigational or licensed vaccine against shigella, cholera, ETEC and\u002For LT toxin.\n26. Who are dependent of the Sponsor, of the investigational team or his\u002Fher immediate family or are students of the professors at the clinical study site.\n27. Who have evidence of current excessive alcohol consumption or drug dependence.\n28. Current occupation involving handling of Shigella and ETEC bacteria.\n29. Any other criteria which, in the Investigator's opinion, would compromise the ability of the participant to participate in the study, the safety of the study, or the results of the study.\n\nInclusion \u002F Exclusion criteria for challenge\n\nOnly participants meeting the above inclusion\u002Fexclusion criteria and the additional following criteria at Stage 2 study entry are eligible to be in Stage 2:\n\n1. Who received 4 doses of vaccine or placebo.\n2. Who are SARS-COV-2 negative.\n3. Who do not have an ongoing grade 2 or higher AE.\n4. Who have negative pregnancy test (participants with child-bearing potential).\n5. Who have not experienced diarrhea in the 7 days before challenge.\n6. Who have not taken antibiotics, probiotics, prebiotics or synbiotics in the previous 7 days before challenge.\n7. Who did not use anti-diarrheal, anti-constipation drugs within 7 days before challenge.\n8. Who did not use proton pump inhibitors, H2 blockers or antacid therapy 48 hours prior to challenge.","50 Years",{"count":87,"type":21},72,[24],"The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T.\n\nIn Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10\\^10 CFU. This dose was tested in a Phase 1 trial and found to be safe when given 4 times with an interval of 3 days between each dose.\n\nThe efficacy of ShigETEC vaccination will be evaluated in Stage 2 of this study, when participants will be challenged with S. flexneri 2457T.\n\nThe study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.",[28],"2025-07-07",{"date":93,"type":42},"2025-07-08",{"date":95,"type":21},"2025-06-30",{"date":97,"type":21},"2027-05-23",{"name":99,"class":76},"Eveliqure Biotechnologies GmbH"]