[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651939":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":31,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":31,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":97,"whyStopped":31,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Biocidin REMOVE","EXPERIMENTAL","Participants receive Biocidin REMOVE capsules, a herbal preparation supplied as a 665 mg capsule containing 325 mg of the active proprietary blend. Dosing begins with a 9-day titration, increasing by one capsule every three days: one capsule once daily on Days -9 to -7, one capsule twice daily on Days -6 to -4, and two capsules in the morning with one in the evening on Days -3 to -1. Participants reach the target dose of two capsules twice daily on Day 1 and continue at that dose through Day 28. Capsules are identical in appearance to placebo.",[13],"Drug: Biocidin REMOVE",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive matching placebo capsules, identical in appearance to Biocidin REMOVE and containing no active ingredients. Placebo follows the same 9-day titration and dosing schedule as the experimental arm: one capsule once daily on Days -9 to -7, one capsule twice daily on Days -6 to -4, two capsules in the morning with one in the evening on Days -3 to -1, then two capsules twice daily on Days 1 through 28.",[19],"Drug: Placebo",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Herbal preparation supplied as a 665 mg capsule containing 325 mg of an active proprietary blend, taken by mouth. Participants titrate over 9 days, increasing by 1 capsule every 3 days, to a target dose of 2 capsules twice daily. The target dose is maintained from Day 1 through Day 28. Capsules are identical in appearance to a placebo and are dispensed by the Johns Hopkins Hospital Investigational Drug Service.",[9],[26,27],"Biocidin REMOVE Broad-Spectrum Liquid Capsules","Biocidin Capsules REMOVE",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Matching placebo capsules, identical in appearance to Biocidin REMOVE and containing no active ingredients, taken by mouth on the same schedule: a 9-day titration increasing by one capsule every three days, reaching two capsules twice daily from Day 1 through Day 28.",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Gerry Mullin, MD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Gerry Dr. Mullin, MD","CONTACT","410-502-4270","jhbiocidinstudy@live.johnshopkins.edu",[43],{"facility":44,"status":31,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Johns Hopkins Hospital","Baltimore","Maryland","21287","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-76.61219,39.29038,{"lat":54,"lon":53},[57,60],{"name":58,"role":39,"phone":59,"phoneExt":31,"email":31},"Lisa Datta, PhD","410-933-7495",{"name":61,"role":35,"phone":31,"phoneExt":31,"email":31},"Gerard Mullin, MD",{"type":63,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[65],{"name":66,"class":67},"Biocidin","UNKNOWN","100651939","phase-2-herbal-supplement-biocidin-remove-for-bacterial-overgrowth-in-irritable-bowel-syndrome-100651939",false,"NCT07768267","Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome","A Pilot Study of the Role of an Antimicrobial Herbal Formulation (Biocidin REMOVE) for the Management of Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Irritable Bowel Syndrome (IBS)","Inclusion Criteria:\n\n* Age 18 years or older\n* Irritable bowel syndrome by Rome IV criteria with a positive lactulose breath test for small intestinal bacterial overgrowth, defined as a rise of more than 20 parts per million of hydrogen above baseline in the first 90 minutes of testing and\u002For a methane level of 10 parts per million or greater at any point during the test\n\nOR\n\n* Irritable bowel syndrome by Rome IV criteria with a lactulose breath test showing a \"flat line pattern,\" with exhaled gas levels remaining very low (3 parts per million or less) with no spikes\n* Female participants of childbearing age who are sexually active with male partners must agree to use a highly effective method of contraception, such as abstinence, hormonal contraceptive, intrauterine device, or bilateral tubal occlusion\n\nExclusion Criteria:\n\n* Negative SIBO breath testing at baseline\n* Restricted diets (low carbohydrate, Atkins, gluten-free, low FODMAP, or others)\n* Confirmed celiac disease\n* Immunocompromised (chronic steroids, biologics), CD4 less than 400, AIDS not on therapy, neutropenia, acute and chronic leukemia, lymphoma\n* Portal hypertension\n* Chronic liver disease, defined as: ICD-10 known diagnoses of chronic liver disease; OR known or suspected liver cirrhosis, portal hypertension, or chronic hepatitis; OR serum AST and ALT elevation greater than 2 times the upper limit of normal with decreased serum albumin less than 4.0 g\u002FdL within the last 6 months\n* Pregnant or breastfeeding\n* Diagnosis of inflammatory bowel disease\n* Poorly controlled anxiety or depression despite medication\n* Untreated significant anxiety or depression\n* COVID-19 positive\n* Unable to provide informed consent\n* Insulin dependent or poorly controlled diabetes mellitus (HbA1c greater than 7.0%)\n* Connective tissue disease such as lupus or scleroderma\n* Concurrent narcotic use\n* Antibiotic or probiotic use within 30 days","ALL","18 Years",{"count":78,"type":79},40,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","The goal of this clinical trial is to learn if an herbal supplement called Biocidin REMOVE can clear small intestinal bacterial overgrowth (SIBO) in adults with irritable bowel syndrome (IBS). SIBO means there are too many bacteria in the small intestine. It can make IBS symptoms worse.\n\nThis is a small first study, called a pilot study. Its results will help researchers plan larger studies.\n\nThe main questions it aims to answer are:\n\nDoes Biocidin REMOVE clear SIBO? Does it lower IBS symptoms and improve quality of life? Does it change the mix of bacteria in the gut? Researchers will compare Biocidin REMOVE to a placebo. A placebo is a look-alike capsule that contains no active ingredients. Neither the participants nor the research team will know who gets which one. About 40 adults age 18 and older will take part.\n\nParticipants will:\n\nTake capsules by mouth twice a day for about 5 weeks. Participants will start with a low dose and build up to 2 capsules twice a day.\n\nTake a breath test at the start and at the end of treatment. This test checks for SIBO.\n\nCollect a stool sample at home at the start and at the end of treatment. Answer questions about symptoms and quality of life. Report what was eaten during the study. Come back for one check-in about 4 weeks after treatment ends.",[85,86],"Irritable Bowel Syndrome (IBS)","Small Intestinal Bacterial Overgrowth Syndrome (SIBO)",[88,89,90,91,92,93,94,95,96],"SIBO","IBS","Herbal supplement","Antimicrobial herbal therapy","Gut microbiome","Dysbiosis","Rome IV","Hydrogen breath test","Lactulose breath test","NOT_YET_RECRUITING","2026-08-18",{"date":100,"type":101},"2026-08-19","ACTUAL",{"date":103,"type":79},"2026-09-01",{"date":105,"type":79},"2027-08-10",{"name":5,"class":6},1]