Xyloglucan for the Treatment of Acute Gastroenteritis in Children: Results of a Randomized, Controlled, Clinical Trial.

Cătălin Pleșea Condratovici,Núria Piqué,Vladimir Bacarea

doi:10.1155/2016/6874207

Abstract

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.

Highlights

Acute gastroenteritis, characterized by the onset of diarrhea with or without vomiting, is an extremely common problem in childhood and the second leading cause of morbidity and mortality worldwide, in the first 3 years of life [1, 2], with the majority of deaths concentrated in 35 “low income” countries [3]
Identical numbers of girls and boys were included in the active group (50.00%; n = 9), whereas more girls were included in the control group (66.67%; n = 12) (Table 1)
Rehydration is the key treatment for acute gastroenteritis in children and should be applied as soon as possible [1] to avoid risks and complications, such as life-threatening dehydration, electrolyte disturbances, disturbed digestion, and absorption of nutrients with nutritional deterioration, leading to the need for enteral/parenteral rehydration and consequent hospitalization [1, 2, 14]

Summary

Introduction

Acute gastroenteritis, characterized by the onset of diarrhea with or without vomiting, is an extremely common problem in childhood and the second leading cause of morbidity and mortality worldwide, in the first 3 years of life [1, 2], with the majority of deaths concentrated in 35 “low income” countries [3]. Antibiotic treatment is effective mainly in shigellosis and in the early stage of Campylobacter infection According to these guidelines, other drugs may be effective but require further investigation [1]. Other drugs may be effective but require further investigation [1] In this scenario, there is scope to develop new products that could be used in combination with ORS to reduce the duration and number of symptoms, with a good safety profile [4, 5]. 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). 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.

Methods

Results

Conclusion