Oral rehydration solution containing a mixture of non-digestible carbohydrates in the treatment of acute diarrhea: a multicenter randomized placebo controlled study on behalf of the ESPGHAN working group on intestinal infections.
OBJECTIVE
A randomized, double-blind, placebo-controlled multicenter study to evaluate efficacy and safety of a mixture of non-digestible carbohydrates (NDC) as an adjunct to oral rehydration therapy in treatment of acute infectious diarrhea in children with mild to moderate dehydration.


METHODS
144 boys aged 1 to 36 months with diarrhea defined as three or more watery stools per day for >1 day but <5 days with mild or moderate dehydration (World Health Organization criteria) were randomly assigned to receive hypotonic oral rehydration solution (ORS) (Na 60 mmol/L, glucose 111 mmol/L) with or without a mixture of NDC (soy polysaccharide 25%, alpha-cellulose 9%, gum arabic 19%, fructooligosaccharides 18.5%, inulin 21.5%, resistant starch 7%).


RESULTS
Intention-to-treat analysis did not show significant differences in mean 48 hour stool volume (ESPGHAN-ORS with NDC versus ESPGHAN-ORS, 140 +/- 124 g/kg versus 143 +/- 114 g/kg; P = 0.41). Duration of diarrhea after randomization was similar in both groups (82 +/- 39 hours versus 97 +/- 76 hours, P = 0.24). There were no significant differences in the duration of hospital stay (111 +/- 44 hours versus 126 +/- 78 hours; P = 0.3). Unscheduled intravenous rehydration was similar in both groups (21.4% versus 16.2%, P = 0.42).


CONCLUSIONS
In boys with acute non-cholera diarrhea with mild to moderate dehydration a mixture of non-digestible carbohydrates was ineffective as an adjunct to oral rehydration therapy.
Hoekstra
J H
JH
Department of Paediatrics, Hieronymus Bosch Hospital, 's-Hertogenbosch, The Netherlands. hhoek@knmg.nl
Szajewska
H
H
Zikri
M Abu
MA
Micetic-Turk
D
D
Weizman
Z
Z
Papadopoulou
A
A
Guarino
A
A
Dias
J A
JA
Oostvogels
B
B
D000208:Acute Disease; D002675:Child, Preschool; D003681:Dehydration / Q000628:therapy*; D003967:Diarrhea / Q000628:therapy*; D004040:Dietary Carbohydrates / Q000008:administration & dosage* / Q000627:therapeutic use; D004043:Dietary Fiber / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D005285:Fermentation; D005440:Fluid Therapy; D006801:Humans; D007223:Infant; D007902:Length of Stay; D008297:Male; D015532:Rehydration Solutions / Q000737:chemistry* / Q000627:therapeutic use; D012995:Solubility; D016896:Treatment Outcome
D004040:Dietary Carbohydrates; D004043:Dietary Fiber; D015532:Rehydration Solutions