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Updated: May 12, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Efficacy and safety of a parenteral amino acid solution containing alanyl-glutamine versus standard solution in
Marie-Chantal Struijs1, Thomas Schaible, Ruurd M van Elburg
1Department of Pediatric Surgery, Erasmus MC-Sophia, Rotterdam, The Netherlands. a.e.c.j.m.struijs@erasmusmc.nl
Insights
This pilot study found that alanyl-glutamine (GLN-AA) parenteral nutrition is safe and well-tolerated in infants post-surgery. GLN-AA better reflects infant amino acid needs compared to standard infusions.
Area of Science:
- Pediatric Nutrition
- Clinical Trials
- Parenteral Nutrition
Background:
- Optimal pediatric amino acid (AA) infusion composition is crucial for infant health.
- Parenteral nutrition requires careful consideration of amino acid profiles, especially in surgical infants.
Purpose of the Study:
- To evaluate the safety and efficacy of a novel parenteral AA solution containing alanyl-glutamine (GLN-AA).
- To compare GLN-AA with a Standard-AA solution in infants undergoing surgical interventions.
Main Methods:
- A randomized, double-blind, multicentre pilot trial was conducted.
- Infants received either GLN-AA or Standard-AA for 5-10 days.
- Plasma amino acid profiles, safety, and efficacy parameters were assessed.
Main Results:
- Plasma AA profiles in infants receiving GLN-AA were closer to normal ranges than those receiving Standard-AA.
- No significant clinical or statistical differences in adverse events, safety, or efficacy were observed between groups.
- Infant demographics (gestational age, birth weight) were comparable between treatment groups.
Conclusions:
- The novel GLN-AA parenteral solution is safe and well-tolerated in infants post-surgery.
- GLN-AA more accurately reflects the amino acid requirements of infants compared to standard solutions.
- This first-in-man study supports the use of GLN-AA in pediatric parenteral nutrition.
Background & Aims:
Efforts are directed at reaching the optimal composition of pediatric amino acids (AA) infusions. The goal was to demonstrate the safety and efficacy of a newly developed parenteral AA solution containing alanyl-glutamine (GLN-AA) compared to Standard-AA.
Methods:
This is a randomized (2:1), double-blind, multicentre clinical pilot trial. Infants after surgical interventions were allocated to receive GLN-AA or Standard-AA over a minimum of 5 days to maximum of 10 days. AA profiles in blood samples obtained at baseline, day 7, and end of treatment were compared to normal ranges. Data regarding safety, and efficacy were also collected.
Results:
Infants were comparable for (safety population) gestational age at birth (36 vs 38 weeks), birth weight (2460 vs 2955 g), and day of life during start intervention (1 vs 2 days). Plasma AA profiles in infants treated with GLN-AA (n = 13) were closer the normal ranges than those in infants treated with Standard-AA (n = 6). There were no clinical or statistical differences in adverse events, safety and efficacy parameters between both groups.
Conclusion:
This first-in-man study shows that GLN-AA is safe in infants after surgical interventions, and is well tolerated. Compared to reference values, GLN-AA better reflects the amino acid requirements of the infant.
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