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NCT02319252 Clinical Trial

Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

Malnutrition Clinical Trial

Official title:
Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02319252
Other study ID # Tubes in liver diseases
Secondary ID
Status Completed
Phase N/A
First received December 2, 2014
Last updated April 18, 2018
Start date January 2015
Est. completion date April 2018

Study information
Verified date May 2016
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Gastric tube (Nutricia Flocare® Pur Tube Enlock)
Nutricia Flocare® Pur Tube Enlock, Ch. 12
• Jejunal tube (Nutricia Flocare® Bengmark®)
Nutricia Flocare® Bengmark®, Ch. 10

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus Central Region

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Differences in nutrition intake Nutrition intake, protein intake, oral intake versus tube intake Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
Secondary Differences in patients reported outcomes Questionnaires Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
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