No registrations found.
ID
Source
Brief title
Health condition
Indication for tube nutrition
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastrointestinal tolerance measured by defecation pattern and self-reported GI symptoms.
Secondary outcome
N/A
Background summary
The purpose of this study is to investigate the gastrointestinal tolerance of two enteral nutrition formulae in patients receiving long term tube nutrition
Study objective
Comparison of the gastrointestinal tolerance of two enteral nutrition formulae
Study design
Defecation pattern will be monitored daily throughout the study period. Self-reported GI symptoms will be assessed at baseline, end of the first intervention period (first study product) and end of the second intervention period (second study product).
Intervention
Daily intake of study product.
Total duration of intervention: 4 weeks; 2 weeks first study product followed by 2 weeks second study product.
Specification of intervention:
The study product will replace the tube nutrition that is received by the subject prior to the trial. The tube feeding regimen is similar to pre study feeding regimen.
P.O. Box 7005
M. Klebach
Wageningen 6700 CA
The Netherlands
marianne.klebach@danone.com
P.O. Box 7005
M. Klebach
Wageningen 6700 CA
The Netherlands
marianne.klebach@danone.com
Inclusion criteria
1. Age 18 years or older
2. Receiving enteral nutrition via a nasogastric tube or Percutaneous Endoscopic Gastrostomy (PEG)
3. Use of enteral nutrition as main source of nutrition
4. Written informed consent from either patient or legal representative for patients who cannot consent themselves
Exclusion criteria
1. Use of antibiotics in the past 2 weeks
2. Ulcerative colitis or Crohns disease
3. Presence of colostomy
4. Known intolerance or allergy to ingredients of study product
5. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
6. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
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 |
|---|---|
| NTR-new | NL1414 |
| NTR-old | NTR1474 |
| CCMO | NL19190.072.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |