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CompletedNCT02319252Updated Apr 20, 2018

Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

An interventional study of Gastric tube (Nutricia Flocare® Pur Tube Enlock) and Jejunal tube (Nutricia Flocare® Bengmark®) in Malnutrition and Liver Diseases, Alcoholic, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-20.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Malnutrition
  • Liver Diseases, Alcoholic
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 1,322 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hepatic encephalopathy, grade 3 - 4
  • Anatomic barriers to have a tube placed
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Gastric tube

    A gastric tube is used

    Device: Gastric tube (Nutricia Flocare® Pur Tube Enlock)

  • Active comparator
    Jejunal tube

    A jejunal tube is used

    Device: Jejunal tube (Nutricia Flocare® Bengmark®)

Interventions

  • DeviceGastric tube (Nutricia Flocare® Pur Tube Enlock)

    Nutricia Flocare® Pur Tube Enlock, Ch. 12

  • DeviceJejunal tube (Nutricia Flocare® Bengmark®)

    Nutricia Flocare® Bengmark®, Ch. 10

06

What researchers measure

Primary outcomes

  1. Differences in nutrition intake

    Nutrition intake, protein intake, oral intake versus tube intake

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

Secondary outcomes

  1. Differences in patients reported outcomes

    Questionnaires

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

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, Central Region 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02319252
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Dec 18, 2014
Start date
Jan 2015
Primary completion
Apr 2018
Completion
Apr 2018
Last update
Apr 20, 2018

Study contacts

Palle Bager, PhD
principal investigator · Aarhus University Hospital, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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