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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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