[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621489":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":18,"responsibleParty":39,"collaborators":18,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":18,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":18},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm taking food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin)","EXPERIMENTAL","group receiving 16 fiber-enriched bite-sized pieces (16 g of fiber in total: 8 g of pectin and 8 g of inulin)",[13],"Dietary Supplement: Administration of fibers as a dietary supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm that will not consume the bite-sized pieces","NO_INTERVENTION","Patients in this arm will not consume the bite-sized pieces and will follow the usual care protocol",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","Administration of fibers as a dietary supplement","Food bite-sized pieces containing 16 g of dietary fiber (pectin and inulin).",[9],[26],{"name":27,"affiliation":5,"role":28},"Carine PARE","STUDY_DIRECTOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Dragos CIOCAN, MCU-PH","CONTACT","+33 1 45 37 43 69","dragosmarius.ciocan@aphp.fr",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Anne-Marie CASSARD","+33 6 68 13 66 29","cassard.doulcier@universite-paris-saclay.fr",{"type":40,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100621489","administration-of-fiber-as-a-dietary-supplement-to-improve-the-management-of-alcohol-withdrawal-100621489",false,"NCT07371286","Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal","Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal - Randomized Controlled Open-label Study - FIB-ALC","FIB-ALC","Inclusion Criteria:\n\n* Women or men,\n* aged \\>18 and ≤ 65,\n* French-speaking,\n* active alcohol users (as defined by the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, DSM-5)\n* who agree to be hospitalized for alcohol withdrawal for a period of 7 days\n* Affiliated with or eligible for social security.\n* Negative pregnancy test (for patients of childbearing age)\n\nExclusion Criteria:\n\n* any other addictive disorder (except tobacco),\n* inflammatory bowel disease or any other chronic inflammatory disease,\n* current cancer,\n* metabolic diseases such as obesity (BMI ≥ 30 kg\u002Fm²) kg\u002Fm2) or a history of bariatric surgery,\n* severe cognitive impairment (MMSE \\\u003C 24),\n* psychiatric comorbidities including suicide risk,\n* cirrhosis or significant fibrosis (≥F2) defined by a Fibroscan value \\>7.6 kPa,\n* pregnancy or breastfeeding,\n* taking antibiotics, probiotics, or prebiotics in the 2 months prior to inclusion,\n* taking non-steroidal anti-inflammatory drugs or glucocorticoids in the month prior to inclusion.\n* taking baclofen, disulfiram, naltrexone, or acamprosate.\n* Participation in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable\n* Patients under AME\n* Patients under guardianship, trusteeship, or any other legal protection measure","ALL","19 Years","65 Years",{"count":53,"type":54},138,"ESTIMATED","INTERVENTIONAL",[57],"NA","The goal of this clinical trial is to demonstrate that a fiber-enriched diet (with a high proportion of inulin and pectin) combined with standard care can reduce intestinal permeability in patients with alcohol use disorder (AUD) aged between 19 and 65.\n\nThe hypothesis of our study is that a diet rich in different dietary fibers (mainly inulin and pectin), by modifying the gut microbiota and its metabolites, will induce a decrease in intestinal permeability, restore the composition of the gut microbiota and its metabolites, and further improve abstinence, levels of craving and anxiety, inflammation, steatosis, and hepatic fibrosis in patients with alcohol use disorder.\n\nThe study consists of two parallel groups (a group eating fiber-rich snacks every day for 28 days (in addition to their usual care) versus a group not eating any snacks).\n\nParticipants will be required to provide stool, blood, and saliva samples, and complete questionnaires.",[60,61,62],"Alcohol Use Disorder","Supplementation","Intestinal Permeability",[64,65,66,67,68],"Alcohol","Dietary fibers","Food supplementation","Intestinal permeability","Misuse","NOT_YET_RECRUITING","2026-01-19",{"date":72,"type":73},"2026-01-27","ACTUAL",{"date":75,"type":54},"2026-02",{"date":75,"type":54},{"name":5,"class":6}]