[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536020":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":39,"responsibleParty":57,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Manchester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The 8x5 Diet","ACTIVE_COMPARATOR","The 8x5 Diet is a healthy dietary pattern administered virtually by a specialist dietitian",[13],"Behavioral: The 8x5 Diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Continuation of habitual diet, no dietary changes.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","A virtual, dietitian-counselled, healthy dietary pattern defined by its fat intake, its daily eating pattern, keeping adequately hydrated, having a variety of whole grains, fruit and vegetables, and use of certain plant fibres.",[9],[25],{"name":26,"affiliation":27,"role":28},"Christopher Todd, Professor","The University of Manchester","STUDY_CHAIR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Yvonne McKenzie, MSc","CONTACT","07966878758","yvonne.mckenzie@postgrad.manchester.ac.uk",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Sorrel Burden, PhD","0161 306 1508","sorrel.burden@manchester.ac.uk",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Yvonne McKenzie","RECRUITING","Manchester","Greater Manchester","M13 9PL","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-2.23743,53.48095,{"lat":52,"lon":51},[55,56],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},{"type":58,"investigatorFullName":41,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","PhD Candidate","100536020","the-8x5-diet-for-bile-acid-diarrhoea-a-feasibility-randomised-controlled-trial-100536020",false,"NCT06259396","The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18 years, of any ethnic group, living in the United Kingdom and not planning to move home for the next three months\n* Self-reported diagnosis of bile acid diarrhoea that was confirmed by 7-day SeHCAT testing\n* Self-reported ongoing chronic diarrhoea despite use of appropriate medication\n* Able to participate in either diet group with the intention to remain in the group to which they were assigned for the 8 week study period\n* Body mass index ≥20 kg m-2\n* Able to converse in English (or via their carer, without assistance from an interpreter) using a computer\u002Flaptop, smart phone, or tablet\n* Able to provide informed written consent\n* Able to provide the address of their general practioner so that the research team can inform them of their participation.\n\nExclusion Criteria:\n\n* Unable to provide self-reported written confirmation that their diagnosis of bile acid diarrhoea was by SeHCAT testing\n* Pregnant\u002Fbreastfeeding\u002Fplanning a pregnancy in the next six months\n* Inflammatory bowel disease, previous or current microscopic colitis, or other serious morbidities such as liver disease, pancreatic disease, AIDS\u002FHIV, radiotherapy for cancer, assessed at screening via patient self-report\n* Diarrhoea that is inadequately active: \\<3 stools per day or \\<1 watery stool (Bristol Stool Form types 6-7) per day as the mean of one week\n* Currently participating in another research study or has taken part in the previous 3 months\n* If taking insulin, metformin (other than slow-release), anti-obesity medication, or using commercially available formulated supplements to replace meals in previous three months\n* Use of antibiotics in the previous four weeks\n\nMedically necessary dietary exclusions or issues deemed incompatible with the trial:\n\n* Food allergies, other than oral allergy syndrome\u002Fpollen-food syndrome\n* Exclusion of gluten (i.e. coeliac disease), lactose, biogenic amines, or any other dietary exclusion assessed as unsuitable as screening by the trial team. This includes if the participant knows they would refuse to eat: starchy foods, fruit and vegetables, protein-rich foods, or dairy and alternatives (e.g. following a ketogenic diet)\n* An eating disorder or disordered eating which is active or in the last 12 months\n* Alcohol or drug abuse, or self-harm, or depression, or suicide ideation in the last 12 months\n* Shift worker\n* If unwilling to keep a weighed 7-day food diary","ALL","18 Years",{"count":69,"type":70},76,"ESTIMATED","INTERVENTIONAL",[73],"NA","Bile acid diarrhoea is a common cause of chronic watery diarrhoea. Treatment is life-long medication. However, about 50% of people have ongoing, bothersome diarrhoea. Findings from recent research on diet therapies and food intolerances have been used to develop a healthy dietary pattern called The 8x5 Diet. We will test the practicalities of conducting a randomised controlled trial of this dietary intervention.",[76],"Bile Acid Diarrhea",[78,79,80,81,82],"diet intervention","nutrition","feasibility","diarrhoea","adults","2024-12-10",{"date":85,"type":86},"2024-12-16","ACTUAL",{"date":88,"type":86},"2024-04-02",{"date":90,"type":70},"2025-03-31",{"name":5,"class":6},1]