NCT03587870: ProBoNo

Protein Delivery in Intermittent and Continuous Enteral Nutrition in ICU Patients

Recruiting now NA Last updated 18 November 2025

What this trial tests

NA trial testing Enteral nutrition with Fresubin Intensive in Muscle Wasting in Critically Ill in 68 participants. Currently enrolling.

Timeline

25 March 2019

Primary endpoint
31 December 2025

31 March 2026

Quick facts

Lead sponsor	University Hospital, Basel, Switzerland
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	68
Start date	25 March 2019
Primary completion	31 December 2025
Estimated completion	31 March 2026
Sites	1 location across Switzerland

Drugs / interventions tested

• Enteral nutrition with Fresubin Intensive

Conditions studied

• Muscle Wasting in Critically Ill — all drugs for Muscle Wasting in Critically Ill →

Sponsor

University Hospital, Basel, Switzerland

Who can join

18 and older, any sex, with Muscle Wasting in Critically Ill. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute skeletal muscle wasting in ICU patients is associated with functional impairment and with increased risk of death. Of what we know today, physical disability can persist up to 5 years. Adequate nutrition is the basis for an optimal recovery for ICU patients and for prevention of muscle wasting. Today, continuous feeding is still the standard enteral nutrition form for patients in the ICU to limit the incidence of aspiration. A study of Serpa et al. and Georgia et al. compared the continuous feeding versus a bolus nutrition with a feeding time of 30 - 60 minutes every 4 hours. They showed no statistical differences in complications between both groups.

ProBoNo is a prospective, randomized, controlled pilot study of critically ill patients with a protein- rich formula to explore the impact of continuous or intermittent bolus nutrition on muscle breakdown in ICU patients. The investigators would like to recruit 68 patients during the first 24 hours after surgical intensive care unit admission. Prior beginning of nutrition administration, and on the 7th day thereafter the investigators will perform a muscle biopsy and an ultrasound from the vastus lateralis muscle in both groups.

The primary outcome is the time from 6.00 am of the following day after admission until the patient reaches his daily protein's target quantity. Secondary outcomes include the diameter and densitiy of the hamstrings assessed by ultrasound and histology, the process of gastric residual volume, number of diarrhoea events and laboratory findings like glucose, urea and insulin like growth factor (IGF)-1, all compared between the two time points.

Intermittent feeding is not only more natural and could help to limit the muscle wasting in ICU patients, it is also easier to handle for the ICU caring medical team. A trial from Georgia et al. in 2007 compared continuous to intermittent enteral nutrition. They found that the intermittently fed patients reached their nutrition goal faster than those being continuously nourished. This might in part be explained by feeding interruptions in the continuous feeding regimen. Presumably, preoperative holding of tube feedings in the continuous nutrition group most commonly caused interruptions. Thus, independently from prevention of muscle breakdown, a bolus nutrition would be more attractive.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protein delivery in intermittent and continuous enteral nutrition with a protein-rich formula in critically ill patients-a protocol for the prospective randomized controlled proof-of-concept Protein Bolus Nutrition (Pro BoNo) study.
   Reinhold S, Yeginsoy D, Hollinger A, Todorov A, et al · · 2020 · cited 4× · PMID 32843075 · DOI 10.1186/s13063-020-04635-1
2. Protein delivery in intermittent and continuous enteral nutrition with a protein-rich formula in critically ill patients - A protocol for the prospective randomised controlled proof-of-concept Protein Bolus Nutrition (Pro BoNo) study
   Reinhold S, Yeginsoy D, Hollinger A, Todorov A, et al · · 2020 · DOI 10.21203/rs.2.23374/v3