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Gastrointestinal tolerance of a new enteral nutrition composition in hospitalised patients.


- candidate number9593
- NTR NumberNTR2924
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mei-2011
- Secondary IDsTub.7.C/A Danone Research C Centre for Specialised Nutrition
- Public TitleGastrointestinal tolerance of a new enteral nutrition composition in hospitalised patients.
- Scientific TitleGastrointestinal tolerance of a new enteral nutrition composition in hospitalised patients.
- ACRONYMAcropolis II
- hypothesisGastrointestinal tolerance to the new tube feed composition is equal to control tube feed composition.
- Healt Condition(s) or Problem(s) studiedMalnutrition
- Inclusion criteria1. Age ≥ 18 years;
2. Indication for enteral nutrition via a nasogastric tube or Percutaneous Endoscopic Gastrostomy (PEG);
3. Expected average daily intake of enteral nutrition at least 1000 kcal;
4. Expected to require enteral nutrition for at least 7 days after inclusion;
5. Written informed consent from patient.
- Exclusion criteria1. Tube nutrition in the past two weeks;
2. Gastrointestinal surgery in the past 2 weeks;
3. Surgery involving general anaesthesia in the past 2 weeks;
4. Requiring intensive care;
5. Ulcerative colitis or Crohn's disease;
6. Presence of colostomy or other faecal diversion;
7. Known intolerance or allergy to ingredients of study product;
8. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements;
9. 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
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2011
- planned closingdate1-apr-2012
- Target number of participants50
- InterventionsDuration of intervention: 7 - 14 days.
In most hospitalised patients it will be difficult to predict how long tube feeding will be needed at the moment feeding is started. Therefore subjects are eligible for inclusion if they are expected to be in need of tube nutrition for at least 7 days.
Participation will be ended before day 14 if patients are no longer in need of tube feeding or discharged from the hospital.

1. Intervention group: New tube feed composition;
2. Control group: Control tube feed composition.
- Primary outcomeGastrointestinal tolerance:
1. Defecation pattern;
2. Occurrence and intensity of gastrointestinal symptoms;
3. Number of days target amount of tube feed administration not reached due to signs of intolerance.
- Secondary outcomeStudy product intake.
- TimepointsScreening, Baseline, Day 1, Day 7, Day 14, Follow Up.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc. Marjolein Vossers
- CONTACT for SCIENTIFIC QUERIES Zandrie Hofman
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryIn this trial a new tube feed composition will be compared with control tube feed composition on gastrointestinal tolerance in hospitalised patients.
- Main changes (audit trail)
- RECORD31-mei-2011 - 11-aug-2012


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