The aim of the study is to assess the cost-effectiveness of implementation of tube feeding in hospitalized IBD patients.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The reduction of hospital stay in days of 30%
Secondary outcome
Quality of life and psychopathology by psychological assessment using the IBDQ
questionnaire
Background summary
It is known that nutritional support is an important factor in the treatment of
patients with inflammatory bowel disease (IBD) who experience an exacerbation
leading to admittance to the hospital. We hypothesize that using tube feeding
instead of using oral nutritional supplements can shorten the hospital stay in
this group of patients. This will be studied in a randomized trial.
Study objective
The aim of the study is to assess the cost-effectiveness of implementation of
tube feeding in hospitalized IBD patients.
Study design
Multicenter, randomized study will be performed with two treatment arms.
Intervention
Feeding
Group A will receive standard treatment with liquid oral nutritional
supplements (nutri-drink, 4 times 200ml - 4 times 300kcal - per day). Group B
will recieve standard therapy combined with tube feeding via a nasogastric tube
(nutrison standard, 1500-2000ml per day; 100ml = 100kcal).
Study burden and risks
The nasogastric tube can be experienced as uncomfortable. Aspiration prneumonia
is an infrequent complication of tube placement.
Postbus 2040
3000 CA ROTTERDAM
Nederland
Postbus 2040
3000 CA ROTTERDAM
Nederland
Listed location countries
Age
Inclusion criteria
· Endoscopically or histologically proven Crohn*s disease or ulcerative
colitis before 3 months prior to randomization
· Age 18-70 years
· Written informed consent
· Adequate contraception for males and females during treatment and
follow up (written confirmation)
· All therapy is permitted concomitant therapy
· Patients must be hospitalized
Exclusion criteria
· Pregnancy, breast-feeding
· Any other condition which in the opinion of the investigator would make
the patient unsuitable for enrollment, or could interfere with the patient
participating in and completing the study
· Total parental nutrition
· Bowel perforation
· Short bowel
· Neoplastic condition of the subject
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24552.078.08 |