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New treatment option for Severe Acute Alcoholic Hepatitis
Official title Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients
ClinicalTrials.gov ID: NCT06159244
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Patients aged from 18 to 75 years, having :
- Heavy drinker with Maddrey Score ≥ 32 : PT(second)-PT(control)x4.6+Bilirubine (mg/dl)
- Histological confirmed Alcoholic hepatitis
- Personal consent signed to the trial
You likely can't join if
- Exclusion Criteria:
- Age \ 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...
- Uncontrolled liver complications:
See the full eligibility criteria
- Patients aged from 18 to 75 years, having :
- Heavy drinker with Maddrey Score ≥ 32 : PT(second)-PT(control)x4.6+Bilirubine (mg/dl)
- Histological confirmed Alcoholic hepatitis
- Personal consent signed to the trial
- Exclusion Criteria:
- Age \ 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...
- 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 μmol/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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, Picardie, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, Picardie, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.