Comparison of the gastrointestinal tolerance of two enteral nutrition formulae
ID
Bron
Verkorte titel
Aandoening
Indication for tube nutrition
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Gastrointestinal tolerance measured by defecation pattern and self-reported GI symptoms.
Achtergrond van het onderzoek
The purpose of this study is to investigate the gastrointestinal tolerance of two enteral nutrition formulae in patients receiving long term tube nutrition
Doel van het onderzoek
Comparison of the gastrointestinal tolerance of two enteral nutrition formulae
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 7005
M. Klebach
Wageningen 6700 CA
The Netherlands
marianne.klebach@danone.com
Wetenschappelijk
P.O. Box 7005
M. Klebach
Wageningen 6700 CA
The Netherlands
marianne.klebach@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1414 |
| NTR-old | NTR1474 |
| CCMO | NL19190.072.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |