[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diarrhea-infectious\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diarrhea-infectious":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,83,116,149,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100534332","phase-3-ve303-for-prevention-of-recurrent-clostridioides-difficile-infection-100534332",false,"NCT06237452","VE303 for Prevention of Recurrent Clostridioides Difficile Infection","A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection","RESTORATiVE303","Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population):\n\n* Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months\n\nKey Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):\n\n* Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI\n* OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:\n\n  1. Age ≥ 65 years\n  2. Kidney dysfunction, defined as estimated creatinine clearance \\\u003C 60 mL\u002Fmin\u002F1.73 m\\^2 at the time of the qualifying CDI episode\n  3. History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study\n  4. History of a prior CDI episode between 6 and 12 months prior to enrollment\n  5. Immunosuppression due to an underlying disease or its treatment\n  6. Has undergone solid organ or hematopoietic stem cell transplantation\n\nKey Inclusion Criteria (For enrollment in Stage 1 or 2):\n\n* The qualifying episode of CDI must meet all the following criteria:\n\n  1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days\n  2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI\n  3. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A\u002FB and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA\u002FGDH results, performed at either a local laboratory or the central laboratory\n  4. Diarrhea considered unlikely to have another etiology\n* Prior to receiving any study medication, the participant should:\n\n  1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration.\n  2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \\\u003C 3 loose\u002Funformed bowel movements per 24 hours for at least 2 consecutive days\n* Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing\n* Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization\n\nKey Exclusion Criteria (For both Stage 1 and Stage 2):\n\n* History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI\n* Known or suspected toxic megacolon or small bowel ileus at the time of randomization\n* History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis\n* Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode\n* Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug\n* Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)\n* Probiotics, whether characterized as a dietary\u002Ffood supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.)\n* Absolute neutrophil count (ANC) of \\\u003C 0.5 ×10\\^9 cells\u002FL on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC \\\u003C 1.0 × 10\\^9 cells\u002FL","ALL","12 Years",{"count":20,"type":21},852,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).",[27,28,29,30,31,32,33,34,35,36],"Clostridium Difficile","Clostridium Difficile Infections","Clostridium Difficile Infection Recurrence","Clostridioides Difficile Infection","Clostridioides Difficile Infection Recurrence","CDI","C. Diff Infection","Recurrent Clostridium Difficile Infection","C.Difficile Diarrhea","Diarrhea Infectious","RECRUITING","2026-05-28",{"date":40,"type":41},"2026-06-02","ACTUAL",{"date":43,"type":41},"2024-05-20",{"date":45,"type":21},"2027-10",{"name":47,"class":48},"Vedanta Biosciences, Inc.","INDUSTRY",215,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100634349","the-utility-and-feasibility-of-accessible-diarrhea-etiology-prediction-tool-adept-in-an-informal-healthcare-setting-100634349","NCT07538531","The Utility and Feasibility of Accessible Diarrhea Etiology Prediction Tool (ADEPT) in an Informal Healthcare Setting","A Mobile Health Tool to Improve Antibiotics Stewardship Among Village Doctors in Bangladesh","Inclusion Criteria:\n\n* Village Doctor with antibiotic prescribing authority for children presenting with diarrheal illness\n* Practice in trial location subdistrict\n* Self-report treating a minimum of 5 pediatric diarrhea cases per week\n* Willing to participate in ADEPT training, use ADEPT in clinical practice with pediatric diarrhea patients, and to collect, via an electronic tool, data on patient characteristics and clinical management\n\nExclusion Criteria:\n\n\\- Planning to leave study site prior to completion of study","18 Years",{"count":59,"type":21},30,[61],"NA","Diarrheal disease remains a leading cause of morbidity and mortality for children under 5 globally. Accepted best practice for managing diarrhea in the absence of blood or suspicion of cholera is rehydration, however in resource poor areas antibiotics are still prescribed at high rates due to pressures such as financial incentives, caregiver expectations, and diagnostic uncertainty. Informal healthcare providers often serve as first point of care for pediatric diarrhea patients in low- and middle- income countries (LMICs) and commonly prescribe antibiotics for pediatric diarrhea at high frequencies.\n\nIn this pilot before-after feasibility trial informally trained healthcare providers will use a mobile phone-based application (Accessible Diarrhea Etiology Prediction Tool, ADEPT) which will allow for the exploration of the acceptability, feasibility, and utility of the tool, as well as ADEPTs ability to decrease inappropriate antibiotic prescribing practices.",[36,64,65,66],"Algorithms","Decision Support Systems, Clinical","Clinical Decision-making",[68,69,70,71],"Diarrhea","Treatment Algorithm","mHealth","Antimicrobial stewardship","NOT_YET_RECRUITING","2026-04-13",{"date":75,"type":41},"2026-04-20",{"date":77,"type":21},"2026-04-12",{"date":79,"type":21},"2026-06-30",{"name":81,"class":82},"Daniel Leung","OTHER",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100554417","testing-a-scalable-model-of-the-cholera-hospital-based-intervention-for-7-days-chobi7-100554417","NCT06498817","Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)","CHoBI7","Inclusion Criteria:\n\n* Diarrhea patients presenting with three or more loose stools over a 24h period\n* Having no running water inside of the patient's home\n* Plan to reside in current residence for the next 3 months\n* Have a child \\\u003C5 years in the patient's household\n* Have a working mobile phone in the household\n\nExclusion Criteria:\n\n* No one will be excluded because of age, sex, religion, or sexual preference",true,{"count":92,"type":21},1600,[61],"The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections, diarrheal disease, and stunting among young children in intervention households, and had significant sustained impacts on handwashing with soap behaviors and improved water quality 12 months post intervention. Therefore, the investigators next step in the transition to scale is to: (1) To tailor the CHoBI7 program for delivery in rural health facilities and market test the CHoBI7 Program to determine the feasibility of providing a modified water, sanitation, and hygiene (WASH) package with only a soapy water bottle and chlorine tablets in both urban and rural settings through formative research and engagement of key stakeholders (Formative Research Phase); and (2) To evaluate the effectiveness of delivering the CHoBI7 program in district hospitals and sub-district health complexes in rural areas in terms of increases in WASH behaviors and decreases in diarrheal disease by conducting a randomized controlled trial (RCT) (Intervention Implementation and Evaluation Phase).",[36,96],"Cholera",[98,99,100,101,102,103,104,105],"randomized controlled trial","Bangladesh","cholera","diarrheal diseases","water, sanitation, and hygiene","healthcare facilities","mobile health","child health","2026-04-10",{"date":108,"type":41},"2026-04-15",{"date":110,"type":41},"2024-08-19",{"date":112,"type":21},"2026-12-31",{"name":114,"class":82},"Johns Hopkins Bloomberg School of Public Health",1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100626268","phase-2-the-impact-of-shigellosis-and-recommended-treatment-in-children-100626268","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","6 Months","59 Months",{"count":126,"type":21},700,[128],"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.",[36,131,132],"Shigella","Growth & Development",[134,135,136,137,138,139,68],"shigella","children","randomized clinical trial","weight for age","growth outcomes","Azithromycin","2026-03-27",{"date":142,"type":41},"2026-03-30",{"date":144,"type":41},"2026-03-18",{"date":146,"type":21},"2030-08",{"name":114,"class":82},4,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":169,"locationsCount":170},"100452080","preventative-intervention-for-cholera-for-7-days-100452080","NCT05166850","Preventative Intervention for Cholera for 7 Days","Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo","PICHA-7","Inclusion Criteria:\n\n* Diarrhea patients presenting with three or more loose stools over a 24h period\n* Having no running water inside of their home\n* Plan to reside in Bukavu for the next 12 months\n* Have a child \\\u003C5 years in their household\n* Have a working mobile phone in the household\n\nExclusion Criteria:\n\n* No one will be excluded because of age, sex, religion, or sexual preference\n* Presenting at the health facility with a fever (COVID-19 prevention)",{"count":158,"type":21},2900,[61],"The first objective of our study is to develop a theory-driven evidence-based targeted water, sanitation, and hygiene (WASH) intervention for household members of diarrhea patients in South Kivu, Democratic Republic of the Congo (DRC) through formative research and community engagement. The second objective is to conduct a randomized controlled trial of 2,320 household members of 580 severe diarrhea patients to evaluate the effectiveness of the developed targeted WASH intervention in terms of: 1. reducing diarrheal diseases household members of cholera and severe diarrhea patients; and 2. increasing WASH behaviors.",[96,162,36],"Water-Related Diseases","2025-12-09",{"date":165,"type":41},"2025-12-17",{"date":167,"type":41},"2021-12-22",{"date":112,"type":21},{"name":114,"class":82},2,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":90,"sex":179,"minAge":57,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":182,"phases":4,"briefSummary":183,"conditions":184,"keywords":197,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":115},"100607934","early-life-malnutrition-environmental-enteric-dysfunction-and-microbiome-trajectories-100607934","NCT07195006","Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories","Early Life Diarrhoea Episode(s), Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories From Birth Until 3 Years of Life ; The University of Zimbabwe Birth Cohort Study-2 (UZBCS-2)","UZBCS-2","Inclusion Criteria for Cases:\n\n* MUAC ≤23 cm in pregnancy\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to be staying in the study area for the next 3 years\n* Willing to participate and comply with all study requirements and procedures.\n\nAny pregnant woman meeting the above eligible criteria regardless of HIV status who meet the above inclusion criteria will be invited to participate in the study\n\nInclusion criteria for Controls\n\n* Age, HIV status, gestational age at enrolment, and area residence matched normo-nourished peers with MUAC ≥25 - ≤35 cm\n* Haemoglobin level of ≥11g\u002FdL\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to stay in the study area for the next 3 years\n\nExclusion Criteria\n\n* Acute or chronic conditions in mothers interfering with the study according to the judgment of the investigator (HIV infection is not an exclusion criterion)\n* Presence of severe mental health disorders interfering with study procedures according to the judgment of the investigator.","FEMALE",{"count":181,"type":21},368,"OBSERVATIONAL","Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it. The interaction of the mother with the infant shapes the seeding and the trajectory of the infant intestinal microbiota which is crucial for development of a healthy immune system Malnutrition has been associated with intestinal inflammation, intestinal leakage and reduced calorie absorption. Early life malnutrition and environmental enteric dysfunction (EED) immunopathology remains poorly described in the context of mother-infant dyads. This is essential as malnutrition, poor water, sanitation and hygiene (WASH), including the presence of infectious diseases limit the developmental potential of the exposed infants in SSA, including Zimbabwe. In addition, maternal stress and poor mental health may also affect standard hygiene practices, including how a mother cares for her baby, potentially aggravating EED and the risk of the infant being malnourished.\n\nPrimary outcomes\n\n1. Infant malnutrition and recovery.\n2. Gut dysfunction (gut inflammation, leaky gut, malabsorption, dysbiosis)\n3. Diarrhea episodes, defined as any episode of acute diarrhoea (≥3 passages of loose stool within 24 hours as reported by the mother) occurring before the next study visit.\n\nDefinition of malnutrition outcomes to be assessed in babies born to malnourished women, is a mid- upper arm circumference (MUAC) \\\u003C23cm;\n\n* MUAC for age: Malnourished defined as those below -2 standard (SD) of the World Health Organisation (WHO) reference\n* Weight-for-age: Underweight defined as those below -2SD WHO reference\n* Weight-for-height: Wasted defined as those below -2SD WHO reference\n* Height-for-age: Stunted defined as those below -2SD WHO reference\n* Z-scores (as they are i.e. a continuous variable, taking age of infants into account)\n* A composite variable, any of malnourished, underweight, wasted or stunted.",[185,186,187,188,189,190,36,191,192,193,194,195,196],"Malnutrition Pregnancy","Malnutrition in Children","Malnutrition (Calorie)","Environmental Enteric Dysfunction","Gut Dysbiosis","Gut Permeability, Gut Inflammation","Maternal Stress","Child Mental Health","Natural Killer Cell Mediated Immunity","Mycotoxin Biomonitoring","Environmental Exposures","Cell-Mediated Immune Deficiency",[198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214],"diarrhoeal episodes","short chain fatty acids receptor agonists","intestinal inflammation, leakage and calory extraction","toxins in drinking water and food","macro- and micronutrient composition of breast milk","human anti-Gal antibodies","mitochondria health and nutrient uptake","endothelial dysfunction and oxidative stress","hormonal mediated molecular signalling mechanisms","interaction of epigenetics & socioeconomic factors","microbiota, pathobionts and oral microbiota","metagenomics","undernutrition and intestinal infections","infant mortality, morbidity within 1st 1000 days of life","low mid upper arm circumference","sleep adequacy in maternal mental health","chronic inflammation","2025-09-18",{"date":217,"type":41},"2025-09-26",{"date":219,"type":41},"2025-01-27",{"date":221,"type":21},"2032-12-31",{"name":223,"class":82},"University of Zimbabwe"]