[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629486":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":44,"collaborators":22,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":22,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":22,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":76,"whyStopped":22,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Iuliu Hatieganu University of Medicine and Pharmacy","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IBS group","EXPERIMENTAL","Subjects diagnosed with IBS",[13],"Dietary Supplement: Synbiotic supplement containing probiotic strains, botanical extracts, magnesium, vitamin B1, and L-theanine designed to support gut microbiota balance.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Synbiotic supplement containing probiotic strains, botanical extracts, magnesium, vitamin B1, and L-theanine designed to support gut microbiota balance.","Terranova Microbiome Challenge is a synbiotic dietary supplement containing a Magnifood botanical complex (250 mg) composed of organic fresh freeze-dried artichoke leaf (Cynara scolymus) 50 mg, ginger root\u002Frhizome (Zingiber officinale) 50 mg, bilberry (Vaccinium myrtillus) 50 mg, German chamomile flower (Matricaria recutita\u002FChamomilla) 50 mg, and lemon balm leaf (Melissa officinalis L.) 50 mg. The microflora blend (92 mg) includes Bacillus coagulans (BC10) 2 billion CFU, Bifidobacterium bifidum (novaBBF7) 1 billion CFU, Lactocaseibacillus rhamnosus (G1) 1 billion CFU, and Lactiplantibacillus plantarum (T7) 1 billion CFU. The formulation also contains magnesium (as bisglycinate chelate (TRAACS™) oxide) 50 mg, vitamin B1 (as thiamine mononitrate) 50 mg, and L-theanine extracted from green tea leaf (Camellia sinensis) 25 mg. The supplement is delivered in a vegetarian capsule shell made of hydroxypropyl methylcellulose.",[9],[21],"TERRANOVA Microbiome Challenge",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Rares Candrea, Registered dietitian","CONTACT","+40 748 591 379","adelin.rare.candrea@elearn.umfcluj.ro",[30],{"facility":31,"status":22,"city":32,"state":22,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Department of Pharmaceutical Botany, Univeristy of Medicine and Pharmacy \"Iuliu Hațieganu\", 23 Gheorghe Marinescu Street, 3rd Floor, Cluj-Napoca, Romania","Cluj-Napoca","400337","Romania","RO",{"type":37,"coordinates":38},"Point",[39,40],23.6,46.76667,{"lat":40,"lon":39},[43],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Candrea Rareș","Registered dietitian, PhD(c)","100629486","synbiotic-supplement-with-botanical-extracts-for-gut-microbiota-balance-in-irritable-bowel-syndrome-100629486",false,"NCT07475299","Synbiotic Supplement With Botanical Extracts for Gut Microbiota Balance in Irritable Bowel Syndrome","The Impact of a Synbiotic Supplement Containing Botanical Extracts and Multiple Probiotic Strains on Gut Microbiota Balance in Patients With Irritable Bowel Syndrome: A Pilot Prospective Interventional Study","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Clinically confirmed diagnosis of Irritable Bowel Syndrome documented in the medical record\n* Presence of recurrent gastrointestinal symptoms such as bloating, abdominal discomfort, gas, or bowel habit disturbances (constipation, diarrhea, or mixed pattern) considered clinically relevant by the participant\n* Ability to understand the study procedures and provide written informed consent\n* Willingness to participate for the full duration of the study (approximately 16 weeks) and attend study visits (T0, T1, and Tfinal)\n* Willingness to provide biological samples (blood and stool samples for microbiota analysis) according to the study protocol\n\nExclusion Criteria:\n\n* Known or suspected organic gastrointestinal disease explaining the symptoms (e.g., inflammatory bowel disease, untreated celiac disease, gastrointestinal malignancy)\n* Presence of alarm symptoms such as unexplained gastrointestinal bleeding, significant unintentional weight loss, persistent fever, severe anemia, or signs of acute infection\n* Acute gastrointestinal infection at the time of screening\n* Use of antibiotics within the previous 4-8 weeks prior to baseline\n* Use of probiotic, prebiotic, or microbiota-modifying supplements within 4 weeks prior to baseline that cannot be discontinued\n* Planned major dietary changes or initiation of new treatments for gastrointestinal symptoms during the study period\n* Pregnancy or breastfeeding\n* Known allergy or hypersensitivity to any component of the investigational supplement\n* Any severe comorbid condition or circumstance that, in the opinion of the investigator, could increase risk to the participant or interfere with study results","ALL","18 Years","70 Years",{"count":59,"type":60},8,"ESTIMATED","INTERVENTIONAL",[63],"NA","The goal of this clinical trial is to evaluate whether a synbiotic dietary supplement containing botanical extracts and multiple probiotic strains can improve gastrointestinal symptoms and modulate gut microbiota composition in adults diagnosed with Irritable Bowel Syndrome (IBS).\n\nThe main questions it aims to answer are:\n\nDoes supplementation with the synbiotic product improve functional gastrointestinal symptoms associated with IBS (e.g., bloating, abdominal discomfort, and bowel habit disturbances)?\n\nDoes the intervention lead to measurable changes in gut microbiota composition and selected biological markers compared with baseline measurements?\n\nParticipants will:\n\nundergo baseline evaluation including symptom assessment, blood tests, and stool sample collection for gut microbiota analysis;\n\ncomplete an 8-week observation period without intervention to establish baseline variability;\n\ntake the synbiotic supplement once daily for 8 weeks;\n\nrepeat clinical assessments, blood tests, and gut microbiota analysis during follow-up visits.",[66],"Irritable Bowel Syndrome (IBS)",[68,69,70,71,72,73,74,75],"IBS","Synbiotic","Botanical Extracts","Probiotics","Gastrointestinal Symptoms","Digestive Health","Microbiota Diversity","Irritable Bowel Syndrome","NOT_YET_RECRUITING","2026-03-14",{"date":79,"type":80},"2026-03-16","ACTUAL",{"date":82,"type":60},"2026-04",{"date":84,"type":60},"2027-01",{"name":5,"class":6},1]