NCT06923813

Brief Summary

This study focuses on understanding how well patients who have recovered from an ICU stay absorb nutrients when receiving enteral (tube) feeding. Proper nutrition is crucial for recovery, but we don't fully understand how efficiently enteral feeding works in ICU survivors. The study will use advanced techniques like bomb calorimetry to measure the energy content of stool, and indirect calorimetry to measure patients' resting energy expenditure (REE). This will help assess the effectiveness of enteral feeding in these patients, providing valuable information about their metabolic needs and nutritional status. The study will also look into the environmental impact of enteral feeding, particularly food waste. By understanding how much of the nutrition is absorbed versus excreted, the study hopes to suggest more sustainable feeding practices and reduce unnecessary waste in hospitals. Key Goals:

  • Primary Goal: Measure how much energy from enteral feeding is absorbed by patients post-ICU by analyzing their stool and energy expenditure.
  • Secondary Goal: Assess how enteral feeding can be made more sustainable, with less waste generated from unused nutritional products. This research will help improve nutritional care for ICU patients, enhance recovery, and potentially lead to more environmentally friendly healthcare practices.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Apr 2028

First Submitted

Initial submission to the registry

March 28, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

January 8, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

March 28, 2025

Last Update Submit

April 30, 2026

Conditions

Keywords

PEG tubeindirect calorimetrynasogastric

Outcome Measures

Primary Outcomes (2)

  • caloric absorption efficiency

    the caloric intake from enteral feeding will be compared with the caloric content of the excreted stool. The difference between these two values will provide an estimate of how efficiently the body absorbs the administered nutrients.

    From screening to study completion for the patient, on average 3 days

  • Resting Energy Expenditure (REE)

    The study will measure the resting energy expenditure of post-ICU patients using indirect calorimetry, which provides a real-time measure of the patients' basal metabolic rate and energy needs.

    From screening to study completion for the patient, on average 3 days

Secondary Outcomes (3)

  • Nutrient Absorption Efficiency

    From screening to study completion for the patient, on average 3 days

  • Waste Generation from Enteral Feeding Solutions and Tubing

    From screening to study completion for the patient, on average 3 days

  • Overall Food Waste in Hospitals

    From screening to study completion for the patient, on average 3 days

Study Arms (1)

Participants

EXPERIMENTAL

20 post-ICU patients who are fully enterally fed (PEG- or nasogastric tube). Step-by-Step Process: Every time a patient is included, all steps (caloric intake measurement, stool sample collection, blending, freezing, and freeze drying) will be performed sequentially. Bomb Calorimetry can be conducted either systematicallyfor a few patients at a time or all at once after all samples have been collected.

Other: caloric intake measurementProcedure: stool sample collectionOther: energy expenditure measurement

Interventions

* a nonabsorbable blue dye marker will be administered at the start and end of the stool collection period to precisely indentify the stool produced within a specific time frame. * stool will be collected for three days. Each sample will be collected, weighted and labeled with the date and time, then stored at -20°C. * only stool samples from the appearance of the first dye marker to the appearance of the second dye marker will be saved and analyzed. * bomb calorimetry preparation * blending and dilution: each stool sample will be put into a blender and mixed with an equal amount of water * freeze dying: the diluted stool will be placed into freeze-dye flasks and frozen at -20°C. The next day, the flasks will be placed into a freeze dryer for 48hours. * pellet formation: the freeze-dried samples will be formed into 1-gram pellets and stored until calorimetry * calorimetry analysis: the Parr 6200 isoperibol calorimeter will be used to measure the energy content of the stool pellets

Participants

performing indirect calorimetry to measure the REE of each patient

Participants

Detailed daily tracking of the enteral feeding provided to each patient, inclusing the type and amount of nutritional formula administered. Apart from the enteral intake, supplemental calories provided by infusion (e.g. glucose) will be recorded to ensure accurate measurement of caloric intake.

Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age of 18 years or older
  • minimum ICU stay of 7 days
  • fully dependent on enteral feeding (nasogastric or PEG-tube)
  • ability of the patient or representative to understand and sign written informed consent in Dutch, French or English

You may not qualify if:

  • known inflammatory bowel disease
  • known malabsorptive gastrointestinal disease
  • history of small bowel resection
  • concomitant use of serotoninergic or sympathomimetic medications (oa. setrone, tryptans, antidepressants, methylphenidate, monoamine oxidase inhibitors, tramadol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZ Brussel

Brussels, Belgium

NOT YET RECRUITING

UZ Brussel

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Interventions

Energy Metabolism

Intervention Hierarchy (Ancestors)

Metabolism

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 20 post-ICU patients who are fully enterally fed (PEG- or nasogastric tube)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 11, 2025

Study Start

January 8, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations