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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29051
Enrollment
50
Registered
2011-05-31
Start date
2011-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition Ondervoeding

Interventions

Duration 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 eli
2. Control group: Control tube feed composition.

Sponsors

Danone Research ¨C Centre for Specialised Nutrition
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
Gastrointestinal 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

MeasureTime frame
Study product intake.

Contacts

Public ContactMarjolein Vossers

Danone Research - Centre for Specialised Nutrition P.O.Box 7005

marjolein.vossers@danone.com+31 (0)317 467955

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)