MalnutritionNCT02319252
Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases
A study testing Gastric tube (Nutricia Flocare® Pur Tube Enlock) and Jejunal tube (Nutricia Flocare® Bengmark®) in people with Malnutrition and Liver Diseases, Alcoholic, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Liver Diseases, Alcoholic
- What is being tested?
- Gastric tube (Nutricia Flocare® Pur Tube Enlock) and Jejunal tube (Nutricia Flocare® Bengmark®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcoholic liver disease
- nutrition intake less than 75% of needed intake
- Signed informed consent form
Who cannot join
- Hepatic encephalopathy, grade 3 - 4
- Anatomic barriers to have a tube placed
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Malnutrition, Liver Diseases, Alcoholic
- Being tested
- Gastric tube (Nutricia Flocare® Pur Tube Enlock), Jejunal tube (Nutricia Flocare® Bengmark®)
- Medical subject headings
- Malnutrition, Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Gastric tube | Active comparator | A gastric tube is used Receives: Device: Gastric tube (Nutricia Flocare® Pur Tube Enlock) |
| Jejunal tube | Active comparator | A jejunal tube is used Receives: Device: Jejunal tube (Nutricia Flocare® Bengmark®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in nutrition intake
Nutrition intake, protein intake, oral intake versus tube intake
Measured: 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
Measured: Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Palle Bager, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319252
- Sponsor's protocol ID
- Tubes in liver diseases
- Status last verified
- May 2016
- First submitted
- 2 Dec 2014
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases
- ClinicalTrials.gov ID
- NCT02319252
- Acronym / sponsor ID
- Tubes in liver diseases
- Conditions
- Malnutrition, Liver Diseases, Alcoholic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric tube | Active comparator | Device: Gastric tube (Nutricia Flocare® Pur Tube Enlock)A gastric tube is used |
| Jejunal tube | Active comparator | Device: Jejunal tube (Nutricia Flocare® Bengmark®)A jejunal tube is used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Alcoholic liver disease
- nutrition intake less than 75% of needed intake
- Signed informed consent form
Key exclusion criteria (2 listed)
- Hepatic encephalopathy, grade 3 - 4
- Anatomic barriers to have a tube placed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric tube (Nutricia Flocare® Pur Tube Enlock)Nutricia Flocare® Pur Tube Enlock, Ch. 12 | Device | Gastric tube |
| Jejunal tube (Nutricia Flocare® Bengmark®)Nutricia Flocare® Bengmark®, Ch. 10 | Device | Jejunal tube |
Primary outcome
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
1 secondary outcome
Differences in patients reported outcomes
Time frame: Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Palle Bager, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric tube (Nutricia Flocare® Pur Tube Enlock) and Jejunal tube (Nutricia Flocare® Bengmark®) in people with Malnutrition and Liver Diseases, Alcoholic, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in nutrition intake (time frame: Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.