[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600172":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Adamas Biotech S.r.l.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GROUP 1: active group who will take verum","EXPERIMENTAL","Subjects who will take the food supplement. The daily consumption of the food supplement provides: green tea extract (Camellia sinensis (L.) Kuntze - folium) 300 mg, as a green capsule, and a pool of probiotics (Lactobacillus rhamnosus LRH020 2x10\\^9 UFC, Bifidobacterium lactis BL050 2x10\\^9 UFC, Lactobacillus plantarum PBS067 2x10\\^9 UFC), as a white capsule.",[13],"Dietary Supplement: food supplement based on a mixture of green tea extract and a pool of probiotics.",{"label":15,"type":16,"description":17,"interventionNames":18},"GROUP 2: subjects who will take PLACEBO","PLACEBO_COMPARATOR","Subjects who will take daily: 1 capsule\u002Fday of maltodextrin (500 mg) with a green shell, and 1 capsule\u002Fday of maltodextrin (500 mg) with a white shell for 56 days.",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","food supplement based on a mixture of green tea extract and a pool of probiotics.","two capsules of food supplement (verum) or placebo, daily for 56 consecutive days. The daily consumption of the food supplement provides: green tea extract (Camellia sinensis (L.) Kuntze - folium) 300 mg, as a green capsule, and a pool of probiotics (Lactobacillus rhamnosus LRH020 2x10\\^9 UFC, Bifidobacterium lactis BL050 2x10\\^9 UFC, Lactobacillus plantarum PBS067 2x10\\^9 UFC), as a white capsule.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","1 capsule\u002Fday of maltodextrin (500 mg) with a green shell, and 1 capsule\u002Fday of maltodextrin (500 mg) with a white shell for 56 days. The two colours are applied to maintain the binding.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Alessandra Baldi","CONTACT","+393483854114","alessandra.baldi.alimenti@gmail.com",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"COMEGEN Soc. Coop. Sociale","RECRUITING","Naples","80126","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],14.26811,40.85216,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Matteo Laringe","+ 39 081\u002F6174566","comegen@comegen.org",{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100600172","the-beneficial-effects-on-the-intestinal-function-of-a-food-supplement-based-on-an-extract-of-green-tea-and-a-pool-of-probiotics-in-subjects-with-irritable-bowel-syndrome-with-predominance-of-constipation-100600172",false,"NCT07094035","The Beneficial Effects on the Intestinal Function of a Food Supplement Based on an Extract of Green Tea and a Pool of Probiotics in Subjects With Irritable Bowel Syndrome With Predominance of Constipation","Efficacy Study of a Food Supplement Based on an Extract of Green Tea (Camellia Sinensis (L.) Kuntze - Folium) and a Pool of Probiotics (L. Plantarum, L. Rhamnosus and B. Animalis Subsp. Lactis) for the Management of Gastrointestinal Discomfort and for the Maintenance of the Balance of Intestinal Function in Subjects With Irritable Bowel Syndrome (Irritable Bowel Syndrome - IBS) With Predominance of Constipation (IBS-C): Single-center, Controlled, Randomized, Parallel-arm, Double-blind Clinical Trial.","Inclusion Criteria:\n\n* aged between 18 and 70 years\n* able to understand and sign informed consent\n* HIV negative test\n* negative pregnancy test\n* With IBS symptoms for at least 3 months (with onset at least 6 months earlier)\n* recurrent abdominal pain at least 1 day a week, associated with two or more of the following criteria: associated with the act of defecation, associated with a change in the frequency of bowel movements, associated with a change in the shape of the stool (Rome IV diagnostic criteria)\n* who have less than three BM\u002Fwk and at least one of the following conditions:\n\n  * in more than 25%\\* of defecatory acts\n  * lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements\n  * feeling of incomplete evacuation in more than 25% of defecations\n  * feeling of anorectal obstruction\u002Fblockage in more than 25% of defecations\n  * carry out manual manoeuvres to facilitate evacuation in more than 25% of defecations\n* Able to understand and comply with the requirements of the protocol.\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* HIV positive\n* do not meet inclusion criteria.","ALL","18 Years","70 Years",{"count":69,"type":70},64,"ESTIMATED","INTERVENTIONAL",[73],"NA","The study will aim to evaluate the effectiveness of the use of a food supplement, based on a green tea extract (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis), in the management of gastrointestinal distress in the general population and in subjects with IBS in the predominant form of IBS-C, with an impact on quality of life.\n\nThe primary outcome is the overall improvement of perceived gastrointestinal symptoms in subjects with IBS in the predominant form of IBS-C; than the secondary outcomes are the 1) assessment of the impact of constipation on perceived quality of life in the last 4 weeks, 2) effectiveness in improving stool consistency, 3) effectiveness of the frequency of bowel movements, 4) efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS, 5) effectiveness of the decrease in frequency in the use of salvage treatments 6) efficacy against abdominal pain to be evaluated separately from intestinal discomfort 7) evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin and 8) probiotic colonization rate, improving the quality of life of the subjects affected by IBS-C.",[76],"IBS, Constipation Predominant",[78,79,80,81],"IBS, constipation predominant","Food Supplement","Green tea extract","probiotics","2025-07-31",{"date":84,"type":85},"2025-08-05","ACTUAL",{"date":87,"type":85},"2025-07-30",{"date":89,"type":70},"2025-10",{"name":5,"class":6},1]