The EAL is seeking RDNs and NDTRs who work with patients, clients, or the public to treat children and adolescents living with type 1 diabetes, for participation in a usability test and focus group. Interested participants should email a professional resume to by July 15, 2024.

CI: Supplemental Enteral Glutamine (2010)

Spindler-Vesel A, Bengmark S, Vovk I, Cerovic O, Kompan L. Synbiotics, prebiotics, glutamine or peptide in early enteral nutrition: A randomized study in trauma patients. J Parenter Enteral Nutr. 2007 Mar-Apr; 31 (2): 119-126.
PubMed ID: 17308252
Study Design:
Randomized Controlled Trial
A - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To determine the effect of symbiotics, probiotics, glutamine or peptide in early enteral feeding on outcomes in critically-ill multiple trauma patients.

Inclusion Criteria:
  • Multiple injuries with ISS score >18
  • At least a four-day ICU stay.
Exclusion Criteria:

Not described.

Description of Study Protocol:


20-bed university hospital surgical ICU


RCT; random allocation by use of closed envelopes

Blinding used

Objective laboratory values


 EN feeding regimen (four groups)

  • Alitraq (per 100ml: 5.25g protein, 16.5g carbohydrate, 1.55g fat, 1.55g glutamine, 446mg arginine, 154mg α linolenic acid); 480mOs/L
  • Novasource (per 100ml: 4.1g protein, 14.4g carbohydrate, 3.5g fat, 2.2g fermentable fiber); 228mOs/L
  • Nutricomp peptide (per 100ml: 4.5g hydrolyzed protein, 16.8g carbohydrate, 1.7g fat); 400mOs/L
  • Nutricomp standard (per 100ml: 3.7g hydrolyzed protein, 13.7g carbohydrate, 3.3g fat); 240mOs/L; this group also received supplement containing Pediococcus pentosaceous, Lactococcus raffinolactis, Lactobacillus paracasei, Lactobacillus plantarum, and 2.5g each of β-glucan, inulin, pectin and resistant starch.

 Statistical Analysis

  • Descriptive statistics
  • Mann-Whitney U test and X2 for numeric variables
  • Fisher's exact test for categorical variables
  • Pearson's correlation test for associations among variables
  • P<0.05 statistically significance set a priori.
Data Collection Summary:

Timing of Measurements

  • APACHE II score at ICU admission
  • MOF score daily until day seven or until discharge from ICU
  • Procalcitonin measured daily.

Dependent Variables

  • Mechanical ventilation (days)
  • Length of stay in ICU (days) 
  • Incidence of MOF (MOF score daily as three-point scale: 0=not present; 1=moderate; 2=severe)
  • Infectious morbidity (number of infections; microbial specimens cultured and measured by CDC standards)
  • Intestinal permeability (lactulose/mannitol excretion).

Independent Variables

EN formula


Description of Actual Data Sample:
  • Initial N: 113 (87% male)
  • Attrition: Not applicable
  • Age: 41±18.9
  • Ethnicity: Not described
  • Other relevant demographics:
    • ISS 30±11
    • APACHE II score 13±7
    • Average Multiple Organ Failure score 3.1±1.3
  • Anthropometrics: (e.g., were groups same or different on important measures)
  • Location: Slovenia.


Summary of Results:

Key Findings

Variables A. Glutamine B. Soluble Fiber C. Peptide D. Probiotics+Fiber Statistical Significance
  N=32 B=29 N=26 N=26  
All infections 16  17  13  5* 

NS difference among groups

* Group D different from combined A, B, C groups; P=0.0003 

Pneumonia 11  12  11 

NS among groups

* Group D different from combined A, B, C groups; P=0.003 

Other Findings

  • No significant differences in days on mechanical ventilation, ICU LOS or MOF scores
  • Intestinal permeability decreased significantly (P<0.05) from day four to day seven only in group D.
Author Conclusion:

The EN formula with synbiotics was superior as those patients "did better than the others" with lower intestinal permeability and fewer infections.

Funding Source:
Government: Ministry of Science of the government of Republic of Slovenia
Reviewer Comments:

This paper has many tables that compare one group with another; however, results not presented with all four groups in one table except for infection rate. It has a neutral quality review because there is no table comparing the four groups at baseline; thus it was clear whether the groups were comparable (validity question #3).

Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? ???
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? ???
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) ???
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? Yes
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? N/A
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? ???
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes