[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ibs-constipation-predominant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ibs-constipation-predominant":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100618878","co-development-and-validation-of-colonic-symptom-pictograms-for-young-people-100618878",false,"NCT07337343","Co-Development and Validation of Colonic Symptom Pictograms for Young People","Inclusion Criteria:\n\nChildren and Young people are aged between 8-17 years,\n\n* have lower gut or constipation symptoms,\n* can communicate in English or be supported to participate by a caregiver, whānau, or other responsible person. Phase Four will include international invitations to participants with lower gut or constipation symptoms. Healthy volunteers will not be recruited.\n\nExclusion Criteria:\n\n* Children and Young people with developmental or cognitive disorder that precludes their ability to understand the study,\n* Children and Young people who do not have access to a digital device with internet connectivity,\n* unable to read English,\n* parent does not consent",true,"ALL","8 Years","17 Years",{"count":20,"type":21},120,"ESTIMATED","OBSERVATIONAL","Severe constipation affects 10% of children, often leading to significant physical and emotional distress. While constipation is commonly associated with impaired bowel movements, it is fundamentally linked to abnormalities in colonic motility - the coordinated contractions that facilitate passage of stool through the colon and out of the body. Diagnosis of constipation is based upon the Rome IV criteria, which assess symptoms as reported or remembered over the previous 3 months.\n\nHowever, reporting symptoms experienced can be challenging for children and young people for many reasons, such as the overlap of sensations, including fullness, bloating, and discomfort, and an inability to recall or precisely distinguish and describe what they are feeling.\n\nThis study intends to design, develop, and validate symptom pictograms for children aged 8-17 with colonic or lower gut symptoms.",[25,26,27,28,29,30],"Constipation - Functional","Abdominal Pain (AP)","Nausea and Vomitting","Bloating","Flatulence","IBS, Constipation Predominant",[32,33,34,35],"children and adolescents","pictograms","co-design","validation","NOT_YET_RECRUITING","2026-01-02",{"date":39,"type":40},"2026-01-13","ACTUAL",{"date":42,"type":21},"2026-01-01",{"date":44,"type":21},"2027-04-01",{"name":46,"class":47},"University of Auckland, New Zealand","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"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","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.","18 Years","70 Years",{"count":58,"type":21},64,"INTERVENTIONAL",[61],"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.",[30],[65,66,67,68],"IBS, constipation predominant","Food Supplement","Green tea extract","probiotics","RECRUITING","2025-07-31",{"date":72,"type":40},"2025-08-05",{"date":74,"type":40},"2025-07-30",{"date":76,"type":21},"2025-10",{"name":78,"class":79},"Adamas Biotech S.r.l.","INDUSTRY",1]