Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06159244

Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-25

200

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire, Amiens

Lead Sponsor

C

CH Montdidier

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 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. The 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. The 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.

CONDITIONS

Official Title

Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged from 18 to 75 years
  • Heavy drinkers with Maddrey Score 65 32
  • Histologically confirmed alcoholic hepatitis
  • Signed personal consent to join the trial
  • No exclusion criteria present
Not Eligible

You will not qualify if you...

  • Age under 18 years or over 75 years
  • Pregnant or lactating females
  • No personal consent given
  • Other liver diseases such as hepatitis B, hepatitis C, acetaminophen hepatotoxicity, biliary obstruction, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, alpha 1 antitrypsin deficiency, or Wilson disease
  • Uncontrolled liver complications like recent upper gastrointestinal bleeding or active sepsis
  • Current treatment with antibiotics
  • Presence of liver cancer or other extrahepatic malignancies
  • Type 1 hepatorenal syndrome or renal failure requiring renal replacement therapy
  • Grade 4 hepatic encephalopathy
  • Dependence on inotropic or ventilatory support
  • Disseminated intravascular coagulation
  • Intestinal paralysis
  • History of liver transplantation
  • HIV infection
  • Intestinal inflammatory diseases such as Crohn's disease or ulcerative colitis
  • Clostridium difficile infection
  • Clinical suspicion of pneumonia
  • Uncontrolled sepsis
  • Acute alcoholic pancreatitis
  • Uncontrolled alcohol withdrawal syndrome
  • Severe cardiac or respiratory conditions

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Amiens Picardie

Amiens, Picardie, France, 80054

Actively Recruiting

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Research Team

E

Eric Nguyen-Khac, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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