Skip to main content
OpenTrials
Completed

NCT Number: NCT02319252

Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

The study is an unblinded randomized trial, designed to examine whether gastric- or jejunal feeding tubes are the most effect full to feed patients with alcoholic liver diseases and non-sufficient oral intake.

The primary outcome will be differences in nutrition intake between the groups. Secondary outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients' quality of life, nausea & vomiting.

The study will include 40 patients at Aarhus University Hospital, Denmark.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malnutrition Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Liver Diseases Liver Diseases, Alcoholic Nutrition Disorders Nutritional and Metabolic Diseases Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Central Region, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Alcoholic liver disease
  • nutrition intake less than 75% of needed intake
  • Signed informed consent form

Exclusion criteria

  • Hepatic encephalopathy, grade 3 - 4
  • Anatomic barriers to have a tube placed

Treatment and study plan

Gastric tube (Nutricia Flocare® Pur Tube Enlock)

Device

Nutricia Flocare® Pur Tube Enlock, Ch. 12

Jejunal tube (Nutricia Flocare® Bengmark®)

Device

Nutricia Flocare® Bengmark®, Ch. 10

Primary outcomes

  1. Differences in nutrition intake

    Time frame: Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months

    Nutrition intake, protein intake, oral intake versus tube intake

Secondary outcomes

  1. Differences in patients reported outcomes

    Time frame: Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months

    Questionnaires

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 18, 2014
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.