search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Acropolis study


- candidate number4170
- NTR NumberNTR1474
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-okt-2008
- Secondary IDsNL19190.072.08 Danone Research
- Public TitleAcropolis study
- Scientific TitleEvaluation of gastrointestinal tolerance of two enteral nutrition formulae
- ACRONYMAcropolis study
- hypothesisComparison of the gastrointestinal tolerance of two enteral nutrition formulae
- Healt Condition(s) or Problem(s) studiedGastrointestinal tract, Nutrition, Enteral nutrition
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-okt-2008
- planned closingdate30-jun-2009
- Target number of participants30
- InterventionsDaily 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.
- Primary outcomeGastrointestinal tolerance measured by defecation pattern and self-reported GI symptoms.
- Secondary outcomeN/A
- TimepointsDefecation 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).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M. Klebach
- CONTACT for SCIENTIFIC QUERIES Zandrie Hofman
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryThe purpose of this study is to investigate the gastrointestinal tolerance of two enteral nutrition formulae in patients receiving long term tube nutrition
- Main changes (audit trail)
- RECORD3-okt-2008 - 15-okt-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl