Gastrointestinal tolerance of erythritol-containing beverage in young children: a double-blind, randomised controlled trial.
OBJECTIVE
To determine gastrointestinal (GI) responses and maximum tolerated dose of erythritol in young children given as a single oral dose in a 250-ml non-carbonated fruit-flavoured beverage in between meals. This is a multicentre double-blind study with sequential design for multiple dose groups and randomised crossover for comparators of placebo vs dose.


METHODS
A total of 185 healthy young children aged 4-6 years were recruited at three clinical investigation centres after informed consent of both parents; 184 children completed the study. Children were included in one of the four dose groups (5, 15, 20 or 25 g erythritol) and exposed randomly to only one single dose vs an isosweet sucrose placebo. After consumption in the clinic and an observation period, GI symptoms and stooling patterns were recorded during the next 48 h.


RESULTS
Statistically significantly more episodes of diarrhoea and/or severe GI symptoms were observed in the 20 and 25  g groups compared with placebo, but not in the 5 and 15  g groups. Stool consistency, as measured by Bristol stool scale, was lower in the 15-, 20- and 25 g groups for the first 24 -h period, but not at later time points. Incidences of nausea, vomiting, borborygmi, excess flatus and abdominal pain were not significantly different from the placebo controls at all doses of erythritol.


CONCLUSIONS
Rapid ingestion of up to and including 15 g (6% w/v) of erythritol in a beverage in between meals by young children aged 4-6 years was well tolerated. The no observed effect level for diarrhoea and/or severe GI symptoms was 15 g (0.73 g/kg body weight (bw)). Children appeared not to be more sensitive to the GI effects of erythritol than published for adults on a g/kg bw basis.
Clinical Investigation Centre CIC1526, Robert Debré Hospital, Paris, France.
E
E
Jacqz-Aigrain
Clinical Investigation Centre, Louis Pradel Hospital, Bron, France.
B
B
Kassai
Clinical Investigation Centre, Louis Pradel Hospital, Bron, France.
C
C
Cornu
Biofortis Clinical, Nantes, France.
J-M
JM
Cazaubiel
Biofortis Clinical, Nantes, France.
B
B
Housez
Biofortis Clinical, Nantes, France.
M
M
Cazaubiel
Biofortis Clinical, Nantes, France.
J-M
JM
Prével
ClinData Services, Biometrics, Fort Collins, CO, USA.
M
M
Bell
A
A
Boileau
Cargill R&D Centre Europe, Nutrition and Regulatory, Vilvoorde, Belgium.
P
P
de Cock
D015746:Abdominal Pain / Q000209:etiology; D001628:Beverages / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D018592:Cross-Over Studies; D003967:Diarrhea / Q000453:epidemiology / Q000209:etiology* / Q000503:physiopathology / Q000652:urine; D004038:Diet, Reducing; D004311:Double-Blind Method; D004896:Erythritol / Q000008:administration & dosage / Q000009:adverse effects* / Q000652:urine; D005260:Female; D005759:Gastroenteritis / Q000453:epidemiology / Q000209:etiology* / Q000503:physiopathology / Q000652:urine; D006801:Humans; D015994:Incidence; D008297:Male; D064427:Nutritive Sweeteners / Q000008:administration & dosage / Q000009:adverse effects* / Q000378:metabolism; D065667:Renal Elimination; D012720:Severity of Illness Index; D062410:Snacks
D064427:Nutritive Sweeteners; D004896:Erythritol