Title
Locust bean gum safety in neonates and young infants: An integrated review of the toxicological database and clinical evidence
Author
Meunier, L.
Garthoff, J.A.
Schaafsma, A.
Krul, L.
Schrijver, J.
van Goudoever, J.B.
Speijers, G.
Vandenplas, Y.
Publication year
2014
Abstract
Locust bean gum (LBG) is a galactomannan polysaccharide used as thickener in infant formulas with the therapeutic aim to treat uncomplicated gastroesophageal reflux (GER). Since its use in young infants below 12. weeks of age is not explicitly covered by the current scientific concept of the derivation of health based guidance values, the present integrated safety review aimed to compile all the relevant preclinical toxicological studies and to combine them with substantial evidence gathered from the clinical paediatric use as part of the weight of evidence supporting the safety in young infants below 12. weeks of age. LBG was demonstrated to have very low toxicity in preclinical studies mainly resulting from its indigestible nature leading to negligible systemic bioavailability and only possibly influencing tolerance. A standard therapeutic level of 0.5. g/100. mL in thickened infant formula is shown to confer a sufficiently protective Margin of Safety. LBG was not associated with any adverse toxic or nutritional effects in healthy term infants, while there are limited case-reports of possible adverse effects in preterms receiving the thickener inappropriately. Altogether, it can be concluded that LBG is safe for its intended therapeutic use in term-born infants to treat uncomplicated regurgitation from birth onwards. © 2014 The Authors. Chemicals/CAS: galactomannan, 11078-30-1
Subject
Life
RAPID - Risk Assessment Products in Development
ELSS - Earth, Life and Social Sciences
Biomedical Innovation
Health
Healthy Living
Carob bean gum
Gastro-oesophageal reflux
Infant formula
Infants
Locust bean gum
Regurgitation
Thickener
Food additive
Galactomannan
Locust beam gum
Polysaccharide
Unclassified drug
Acute toxicity
Artificial milk
Carcinogenicity
Chemical structure
Chronic toxicity
Dietary intake
Food composition
Food safety
Genotoxicity
Human
Hypersensitivity
In vitro study
In vivo study
Nonhuman
Nutritional assessment
Priority journal
Reproductive toxicity
Safety
Surface property
Teratogenicity
Thickness
Toxicity testing
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http://resolver.tudelft.nl/uuid:a9e42258-0be5-434a-b7a5-5bbda1e852cc
DOI
https://doi.org/10.1016/j.yrtph.2014.06.023
TNO identifier
513388
ISSN
1096-0295
Source
Regulatory Toxicology and Pharmacology, 70 (1), 155-169
Document type
article