title: Locust bean gum safety in neonates and young infants: an integrated review of the toxicological database and clinical evidence.
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 12weeks 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 12weeks 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 0.5g/100mL 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.
authors.affiliation: Danone Food Safety Center, Utrecht, The Netherlands. Electronic address: leo.meunier@danone.com.
authors.forename: Leo
authors.initials: L
authors.lastname: Meunier
authors.affiliation: Danone Food Safety Center, Utrecht, The Netherlands.
authors.forename: Jossie A
authors.initials: JA
authors.lastname: Garthoff
authors.affiliation: FrieslandCampina, Amersfoort, The Netherlands.
authors.forename: Anne
authors.initials: A
authors.lastname: Schaafsma
authors.affiliation: TNO, Zeist, The Netherlands.
authors.forename: Lisette
authors.initials: L
authors.lastname: Krul
authors.affiliation: Danone Nutricia Early Life Nutrition, Schiphol Airport, The Netherlands.
authors.forename: Jaap
authors.initials: J
authors.lastname: Schrijver
authors.affiliation: Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands; Department of Pediatrics, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Goudoever
authors.affiliation: General Health Effects Toxicology Safety Food (GETS), Nieuwegein, The Netherlands.
authors.forename: Gerrit
authors.initials: G
authors.lastname: Speijers
authors.affiliation: Department of Pediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
authors.forename: Yvan
authors.initials: Y
authors.lastname: Vandenplas
mesh_terms: D001682:Biological Availability; D016208:Databases, Factual; D005685:Galactans / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D005764:Gastroesophageal Reflux / Q000178:diet therapy*; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000737:chemistry*; D007231:Infant, Newborn; D008351:Mannans / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D053149:Plant Gums / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics
chemical_list: D005685:Galactans; D008351:Mannans; D053149:Plant Gums; C017471:locust bean gum
keywords: Carob bean gum; Gastro-oesophageal reflux; Infant formula; Infants; Locust bean gum; Regurgitation; Safety; Thickener