Background.
Xyloglucan, a film-forming agent, improves intestinal mucosa resistance to pathologic damage. The efficacy, safety, and time of onset of the
antidiarrheal effect of
xyloglucan were assessed in children with acute
gastroenteritis receiving
oral rehydration solution (
ORS). Methods. This randomized, controlled, open-label, parallel-group, multicenter, clinical trial included children (3 months-12 years) with acute
gastroenteritis of infectious origin. Children were randomized to
xyloglucan and
ORS, or
ORS only, for 5 days. Diarrheal symptoms, including stool number/characteristics, and safety were assessed at baseline and after 2 and 5 days and by fulfillment of a parent diary card. Results. Thirty-six patients (58.33% girls) were included (n = 18/group). Patients receiving
xyloglucan and
ORS had better symptom evolution than
ORS-only recipients, with a faster onset of action. At 6 hours,
xyloglucan produced a significantly greater decrease in the number of type 7 stools (0.11 versus 0.44; P = 0.027). At days 3 and 5,
xyloglucan also produced a significantly greater reduction in types 6 and 7 stools compared with
ORS alone.
Xyloglucan plus
ORS was safe and well tolerated. Conclusions.
Xyloglucan is an efficacious and safe option for the treatment of acute
gastroenteritis in children, with a rapid onset of action in reducing diarrheal symptoms. This study is registered with ISRCTN number 65893282.