Intensive Enteral Nutrition and Acute Alcoholic Hepatitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01801332
• Date of registration: 27/02/2013
• Prospective Registration: No
• Primary sponsor: Erasme University Hospital
• Public title: Intensive Enteral Nutrition and Acute Alcoholic Hepatitis
• Scientific title: Intensive Enteral Nutrition in Association With Corticosteroids in Severe Acute Alcoholic Hepatitis: a Multicenter, Randomized, Controlled Trial
• Date of first enrolment: February 2010
• Target sample size: 136
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01801332
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Belgium, France

Contacts

• Name: Christophe Moreno, MD, PhD
• Affiliation: Erasme University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Acute alcoholic hepatitis proven by a liver biopsy (necessary histological findings :
neutrophils infiltration, ballooned hepatocytes and Mallory bodies)

- Presence of a severe disease, defined by a Maddrey score higher than or equal to 32,
at screening and in baseline (day 0). Maddrey score = total bilirubin in mg/dl + 4,6
X (Prothrombin time patient in sec - prothrombin time control in sec)

- Age between 18 and 75 years old, extremes included

- Recent jaundice or in recent aggravation (less than 3 months)

- Chronic alcohol consumption (more than 40 g/day)

- Informed consent read, understand and signed by the patient (in case of significant
encephalopathy, a family representative can signed in place of the patient)

- Maximal delay between admission and randomization of 14 days.

Exclusion Criteria:

- Other disease compromising 6 months survival of the patient

- Positive HIV or HCV serology, positive HBs Antigen

- Uncontrolled bacterial or fungal infection (infection must be judged controlled for
at least 3 days)

- Uncontrolled upper GI bleeding (bleeding must be controlled for at least 5 days)

- Type 1 Hepatorenal syndrome (creatinin upper than 2,5 mg/dl), as defined by Salerno F
et al, Gut 2007;56:1310-1318

- History of bariatric surgery

- Pentoxyphilline therapy

- MARS therapy



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Severe Alcoholic Hepatitis

Intervention(s)

Dietary Supplement: intensive nutrition

Dietary Supplement: usual meals

Primary Outcome(s)

survival [Time Frame: 6 months survival]

Secondary Outcome(s)

survival [Time Frame: 1 month]

Secondary ID(s)

NETI HAA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors