CompletedNot Applicable

Evaluation of the Gastro-intestinal Tolerance of an Upgraded Composition of an Enteral Tube Feed for Adults

Netherlands101 participantsStarted 2023-05-23

Plain-language summary

This study evaluates the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years
✓. Using either an enteral tube feed with approximately 1.0 or 1.5 kcal/mL with or without fibers via a nasogastric tube (NGT), nasojejunal (NJT) or Percutaneous Endoscopic Gastrostomy (PEG) for at least 4 weeks prior to screening
✓. Actual and expected average daily intake of enteral nutrition at least 1000 kcal for at least 21 days after the start of baseline period
✓. Written informed consent from subject (or impartial witness after verbal consent of subject)

What they're measuring

Gastro-intestinal tolerance

Timeframe: 7 days in the 1-week baseline period

Gastro-intestinal tolerance

Timeframe: 7 days in the second week of the 2-week intervention period

bowel movement pattern

Timeframe: 7 days in the 1-week baseline period

bowel movement pattern

Timeframe: 7 days in the second week of the 2-week intervention period

Trial details

NCT IDNCT05902806

SponsorNutricia Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-05

View on ClinicalTrials.gov More Enteral Tube Nutrition trials