A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial.

Jakob, Stephan M; Bütikofer, Lukas; Berger, David; Coslovsky, Michael; Takala, Jukka (2017). A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial. Critical care, 21(1), p. 140. BioMed Central 10.1186/s13054-017-1730-1

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Diarrhea is frequent in patients in intensive care units (ICU) and is associated with discomfort and complications and may increase the length of stay and nursing workload.


This was a prospective, double-blind, randomized, controlled single-center pilot study to assess the incidence and frequency of diarrhea and the respective effects of a modified enteral diet (intervention: Peptamen® AF, rich in proteins, medium chain triglycerides and fish oil) compared to a standard diet (control: Isosource® Energy) in 90 randomized adult patients (intervention, n = 46; control, n = 44) with an ICU stay ≥5 days and tube feeding ≥3 days. Tube feeding was initiated within 72 h of ICU admission and continued up to 10 days. The caloric goal was adjusted to needs by indirect calorimetry. Gastrointestinal function, nutritional intake, and nursing workload were recorded. Follow-up was until 28 days after randomization.


Median age was 63.3 (interquartile range (IQR) 51.0-73.2) years and Simplified Acute Physiology Score (SAPS) II was 61.0 (IQR 47.8-74). Time to reach caloric goal (intervention: 2.2 (0.8-3.7) days (median, IQR); control: 2.0 (1.3-2.7) days; p = 0.16), length of time on study nutrition (intervention: 5.0 (3.6-6.4) days; control: 7.0 (5.3-8.7) days; p = 0.26), and calorie intake (intervention: 18.0 (12.5-20.9) kcal/kg/day; control 19.7 (17.3-23.1) kcal/kg/day; p = 0.08) did not differ between groups, with a higher protein intake for Peptamen® group (1.13 (0.78-1.31) g/kg/day vs 0.80 (0.70-0.94); p < 0.001). No difference in diarrhea incidence (intervention group: 29 (64%); control group: 31 (70%); p = 0.652), use of fecal collectors (23 (51%) vs. 24 (55%); p = 0.83), or diarrhea-free days (161 (64%) vs 196 (68%); p = 0.65) was found. Nursing workload and cost for diarrhea care were not different between the groups. In a post-hoc analysis, adjusted for treatment group, age, sex, and SAPS II score, diarrhea was associated with length of mechanical ventilation (9.5 (6.0-13.1) vs. 3.9 (3.2-4.6) days; p = 0.006) and length of ICU stay (11.0 (8.9-13.1) vs. 5.0 (3.8-6.2) days; p = 0.001).


In this pilot study, we found a high incidence of diarrhea, which was not attenuated by Peptamen® AF. Patients with diarrhea stayed longer in the ICU.


ClinicalTrials.gov identifier, NCT01581957 . Registered on 18 April 2012.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)
04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)

UniBE Contributor:

Jakob, Stephan, Bütikofer, Lukas (B), Berger, David, Coslovsky, Michael, Takala, Jukka


600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services




BioMed Central




Tanya Karrer

Date Deposited:

15 Feb 2018 15:44

Last Modified:

20 Feb 2024 14:17

Publisher DOI:


PubMed ID:


Uncontrolled Keywords:

Critically ill Diarrhea Enteral nutrition Intensive care





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