[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627633":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":39,"interventions":54,"overallOfficials":67,"centralContacts":74,"locations":79,"responsibleParty":102,"collaborators":105,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":30,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":30,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":82,"whyStopped":30,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"University of Virginia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Conversion to Glucose Hydrogen Breath Test (GHBT) Negativity at Day 15","GHBT negativity will be defined as no breath hydrogen value ≥20 ppm over the patient's baseline during the course of the test. If any breath hydrogen value during the GHBT is \\>20 ppm over the patient's baseline, the test will be deemed positive.","Day 15",[14,17,21,24,27],{"measure":15,"description":11,"timeFrame":16},"Conversion to GHBT Negativity at Day 45","Day 45",{"measure":18,"description":19,"timeFrame":20},"Average Glucose Hydrogen Breath Test Area Under the Curve","Area under the hydrogen curve will be calculated at baseline, day 15, and day 45. An average of these values will be taken to construct this variable.","Baseline, day 15, day 45",{"measure":22,"description":23,"timeFrame":20},"Fecal Myeloperoxidase","Fecal myeloperoxidase levels as measured by a commercially available ELISA kit.",{"measure":25,"description":26,"timeFrame":20},"Fecal Neopterin","Fecal neopterin levels as measured by a commercially available ELISA kit.",{"measure":28,"description":29,"timeFrame":20},"Fecal Calprotectin","Fecal calprotectin levels as measured by a commercially available ELISA kit.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"SINGLE",[38],"OUTCOMES_ASSESSOR",[40,46,50],{"label":41,"type":42,"description":43,"interventionNames":44},"Metronidazole","EXPERIMENTAL","14-day oral course",[45],"Drug: Metronidazole",{"label":47,"type":42,"description":43,"interventionNames":48},"Trimethoprim-sulfamethoxazole and Metronidazole",[49,45],"Drug: Trimethoprim-sulfamethoxazole (TMP\u002FSMX)",{"label":51,"type":42,"description":43,"interventionNames":52},"Amoxicillin-Clavulanate",[53],"Drug: Amoxicillin-Clavulanate (4:1 formulation)",[55,60,63],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":30},"DRUG","Trimethoprim-sulfamethoxazole (TMP\u002FSMX)","8-10 mg\u002Fkg\u002Fday divided every 12 hours, with a maximum 160 mg\u002Fdose; dosing based on Trimethoprim",[47],{"type":56,"name":41,"description":61,"armGroupLabels":62,"otherNames":30},"Administered alone: 20-30 mg\u002Fkg\u002Fday divided every 8 hours, with a maximum 750 mg\u002Fdose\n\nCo-administered with Trimethoprim-sulfamethoxazole: 35-50 mg\u002Fkg\u002Fday divided every 8 hours, with a maximum 750 mg\u002Fdose",[41,47],{"type":56,"name":64,"description":65,"armGroupLabels":66,"otherNames":30},"Amoxicillin-Clavulanate (4:1 formulation)","20-40 mg amoxicillin\u002Fkg\u002Fday divided every 8 hours, with maximum daily dose of 1,500 mg",[51],[68,71],{"name":69,"affiliation":5,"role":70},"Jeffrey R Donowitz, MD","PRINCIPAL_INVESTIGATOR",{"name":72,"affiliation":73,"role":70},"Rashidul Haque, MBBS, PhD","International Centre for Diarrhoeal Disease Research, Bangladesh",[75],{"name":69,"role":76,"phone":77,"phoneExt":30,"email":78},"CONTACT","434-243-8824","jrd9d@virginia.edu",[80],{"facility":81,"status":82,"city":83,"state":30,"zip":30,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)","RECRUITING","Dhaka","Bangladesh","BD",{"type":87,"coordinates":88},"Point",[89,90],90.40744,23.7104,{"lat":90,"lon":89},[93,97,101],{"name":72,"role":76,"phone":94,"phoneExt":95,"email":96},"880-0171-3093859","3483","rhaque@icddrb.org",{"name":98,"role":76,"phone":99,"phoneExt":30,"email":100},"Tahsin Ferdous, MBBS, MPH","880-0171-6041188","tahsin.ferdous@icddrb.org",{"name":72,"role":70,"phone":30,"phoneExt":30,"email":30},{"type":70,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Jeffrey Donowitz, MD","Associate Professor",[106,109,110,112],{"name":107,"class":108},"National Institutes of Health (NIH)","NIH",{"name":73,"class":6},{"name":111,"class":6},"Virginia Commonwealth University",{"name":113,"class":108},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","100627633","phase-2-comparative-efficacy-of-antibiotics-for-small-intestine-bacterial-overgrowth-in-bangladeshi-children-100627633",false,"NCT07451171","Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children","A Phase II Trial to Prevent Linear Growth Stunting and Malnutrition in Impoverished Children From a Low-Income Country by Treating Small Intestine Bacterial Overgrowth","Inclusion Criteria:\n\n* Positive glucose hydrogen breath test (GHBT)\n* Weight-for-age Z score \\> -1\n* Length-for-age Z score \\> -1\n\nExclusion Criteria:\n\n* Presence of known chronic or congenital illness, including developmental delay\n* Presence of acute gastrointestinal illness in the preceding 14 days\n* Antibiotic use in the preceding 14 days\n* Previous adverse reaction to any of the three study medications or other drugs in the same antibiotic classes\n* Sibling previously enrolled in this study","ALL","1 Year","2 Years",{"count":125,"type":126},60,"ESTIMATED","INTERVENTIONAL",[129],"PHASE2","The purpose of this Phase IIa study is to identify the most effective antibiotic regimen to treat small intestine bacterial overgrowth (SIBO) in impoverished Bangladeshi children.",[132],"Small Intestine Bacterial Overgrowth",[134],"environmental enteric dysfunction","2026-08-14",{"date":137,"type":138},"2026-08-18","ACTUAL",{"date":140,"type":138},"2026-04-18",{"date":142,"type":126},"2026-12-02",{"name":5,"class":6},1]