๐ฌIn plain words
What the trial is, and whether it could suit you
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.
The determination of one or more intestinal microbiota signatures associated with the treatment response Corticoste
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Patients aged from 18 to 75 years, having :
* Heavy drinker with Maddrey Score โฅ 32 : PT(second)-PT(control)x4.6+Bilirubine (mg/dl)
* Histological confirmed Alcoholic hepatitis
* Personal consent signed to the trial
* No exclusion criteria
Exclusion Criteria:
* Age \< 18 years and/or \> 75 years,
* Pregnancy or lactating females,
* No personal consent
* 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.
* Uncontrolled liver complications:
* Upper gastrointestinal bleed by portal hypertension (4 days required for stable condition)
* Active sepsis (4 days required for stable condition)
* Patient currently treated by antibiotic
* Concomitant Liver cancer (HCC) or extrahepatic malignancy
* Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine \>221 ฮผmol/L (\>2.5 mg/dL) or the requirement for renal replacement therapy
* Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria
* Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation)
* Disseminated intravascular coagulation
* Intestinal paralysis
* History of liver transplantation
Other general diseases or severe conditions:
* HIV disease
* Intestinal paralysis
* Intestinal inflammatory disease (Crohn or Ulcerative colitis)
* Clostridium difficilae infection
* Clinical suspicion of pneumonia
* Uncontrolled sepsis
* Acute Alcoholic pancreatitis
* Noncontrolled alcohol withdrawal syndrome
* Cardiac or respiratory bad conditions
CHU Amiens Picardie
Amiens, France
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.
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