[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intestinal-microbiota\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intestinal-microbiota":31},{"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":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100528321","intestinal-microbiota-profiling-in-severe-acute-alcoholic-hepatitis-patients-100528321",false,"NCT06159244","Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients","Intestinal Microbiota Profiling in HAA Patients","HepathAlc-IM","Inclusion Criteria:\n\n* Patients aged from 18 to 75 years, having :\n* Heavy drinker with Maddrey Score ≥ 32 : PT(second)-PT(control)x4.6+Bilirubine (mg\u002Fdl)\n* Histological confirmed Alcoholic hepatitis\n* Personal consent signed to the trial\n* No exclusion criteria\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years and\u002For \\> 75 years,\n* Pregnancy or lactating females,\n* No personal consent\n* Other causes of liver disease: chronic hepatitis B (antigen HBs positive), hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, autoimmune hepatitis, primary biliary cholangitis, primary sclerosis cholangitis, alpha 1 antitrypsine deficiency, and Wilson disease.\n* Uncontrolled liver complications:\n* Upper gastrointestinal bleed by portal hypertension (4 days required for stable condition)\n* Active sepsis (4 days required for stable condition)\n* Patient currently treated by antibiotic\n* Concomitant Liver cancer (HCC) or extrahepatic malignancy\n* Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine \\>221 μmol\u002FL (\\>2.5 mg\u002FdL) or the requirement for renal replacement therapy\n* Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria\n* Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation)\n* Disseminated intravascular coagulation\n* Intestinal paralysis\n* History of liver transplantation\n\nOther general diseases or severe conditions:\n\n* HIV disease\n* Intestinal paralysis\n* Intestinal inflammatory disease (Crohn or Ulcerative colitis)\n* Clostridium difficilae infection\n* Clinical suspicion of pneumonia\n* Uncontrolled sepsis\n* Acute Alcoholic pancreatitis\n* Noncontrolled alcohol withdrawal syndrome\n* Cardiac or respiratory bad conditions",true,"ALL","18 Years","75 Years",{"count":22,"type":23},200,"ESTIMATED","INTERVENTIONAL",[26],"NA","In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial growth and ultimately bacterial translocation. The microbiota of a patient with alcoholic hepatitis is different from that of a patient without alcoholic hepatitis. Acute alcoholic hepatitis has a severe prognosis and corticosteroids are the only first line therapy option, with better survival at 28 days versus placebo. However, mortality remains high at 30% at 3 months, which highlights the importance of seeking intestinal microbiota profile on treatment response.\n\nThe determination of one or more intestinal microbiota signatures associated with the treatment response Corticosteroids plus FMT or Corticosteroids plus placebo will allow the clinician to have a simple and rapid test obtained in 16S RNA analysis to predict the therapeutic response and potentially the best treatment to adopt and to address medical and medico-economic stakes.\n\nThe investigators will first characterize the alcohol-induced dysbiosis by a whole microbiota sequencing in the different groups. Specific bacterial species identify by DNA sequencing should be confirmed by qPCR of 16S rDNA to determine a fingerprint of sAH microbiota. Metabolic properties of intestinal microbiota, such as production of short chain fatty acids, will be analyzed by using HPLC. In the sAH group, evolution of intestinal microbiota will be observed by shotgun DNA sequencing between the day 0 and the day 7 of corticosteroids treatment.\n\nThe analysis of sAH patients' microbiota (day 0) will allow us to obtain a non-responder profile to corticosteroids that can be used as a prognostic marker to use in the clinic. The deliverable is the bacterial fingerprint of the treatment response and its valuation is its use as a predictive tool of the response.",[29,30,31,32],"Severe Acute Alcoholic Hepatitis","Alcohol","Intestinal Microbiota","Corticosteroids",[34,30,31,32],"Severe acute alcoholic hepatitis","RECRUITING","2025-05-21",{"date":38,"type":39},"2025-05-25","ACTUAL",{"date":41,"type":39},"2023-11-15",{"date":43,"type":23},"2028-11",{"name":45,"class":46},"Centre Hospitalier Universitaire, Amiens","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100584236","research-on-the-role-of-probiotics-in-human-intestinal-health-100584236","NCT06886711","Research on the Role of Probiotics in Human Intestinal Health","A Study on the Safety and Efectiveness of Bifidobacterium Bifidum BBi32 in Improving Lntestinal and Lmmune Functions","Inclusion Criteria:\n\n1. Willing to attend 3 follow-up visits during the intervention period\n2. Agree to provide blood, urine, and stool samples twice during the intervention period\n3. Good eyesight, able to read and write, and capable of wearing glasses if needed\n4. Good hearing and able to fully comprehend all instructions during the intervention\n\nExclusion Criteria:\n\n1. Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)\n2. History of serious neurological conditions (e.g., epilepsy, stroke, severe head trauma, meningitis within the last 10 years, brain surgery, brain tumor, or prolonged coma-not including general anesthesia)\n3. History of or currently receiving treatment for mental health disorders such as alcohol\u002Fdrug\u002Fsubstance abuse, schizophrenia, psychosis, or bipolar disorder\n4. Currently taking medication for depression or low mood\n5. Presence of internal organ failure (e.g., heart, liver, or kidney failure)\n6. History of radiation therapy or chemotherapy treatments\n7. Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period\n8. History of hepatitis (B or C), HIV, or syphilis","45 Years",{"count":57,"type":23},45,[26],"Evaluate the efectiveness and safety of Bifidobacterium bifidum BBi32 as a food supplement compared to a placebo in improving intestinal andimmune functions in healthy adults.",[31],[62,63],"Probiotics","Intestinal Barrier Function","NOT_YET_RECRUITING","2025-03-13",{"date":67,"type":39},"2025-03-20",{"date":69,"type":23},"2025-03-10",{"date":71,"type":23},"2025-12-30",{"name":73,"class":74},"Wecare Probiotics Co., Ltd.","INDUSTRY"]