Abstract
BackgroundThere is a strong rationale for the use of agents with film-forming protective properties, like xyloglucan, for the treatment of acute diarrhea. However, few data from clinical trials are available.MethodsA randomized, controlled, open-label, parallel group, multicentre, clinical trial was performed to evaluate the efficacy and safety of xyloglucan, in comparison with diosmectite and Saccharomyces in adult patients with acute diarrhea due to different causes.Patients were randomized to receive a 3-day treatment. Symptoms (stools type, nausea, vomiting, abdominal pain and flatulence) were assessed by a self-administered ad-hoc questionnaire 1, 3, 6, 12, 24, 48 and 72 h following the first dose administration. Adverse events were also recorded.ResultsA total of 150 patients (69.3 % women and 30.7 % men, mean age 47.3 ± 14.7 years) were included (n = 50 in each group). A faster onset of action was observed in the xyloglucan group compared with the diosmectite and S. bouliardii groups. At 6 h xyloglucan produced a statistically significant higher decrease in the mean number of type 6 and 7 stools compared with diosmectite (p = 0.031). Xyloglucan was the most efficient treatment in reducing the percentage of patients with nausea throughout the study period, particularly during the first hours (from 26 % at baseline to 4 % after 6 and 12 h). An important improvement of vomiting was observed in all three treatment groups.Xyloglucan was more effective than diosmectite and S. bouliardii in reducing abdominal pain, with a constant improvement observed throughout the study. The clinical evolution of flatulence followed similar patterns in the three groups, with continuous improvement of the symptom. All treatments were well tolerated, without reported adverse events.ConclusionsXyloglucan is a fast, efficacious and safe option for the treatment of acute diarrhea.Trial registrationEudraCT number 2014-001814-24 (date: 2014-04-28)ISRCTN number: 90311828
Highlights
There is a strong rationale for the use of agents with film-forming protective properties, like xyloglucan, for the treatment of acute diarrhea
According to the World Health Organization (WHO), acute diarrhea is defined as the production of three or more passages of loose or watery stools a day in a 24-h period, for less than 14 days [1, 2]
Inclusion criteria were a minimum age of 18 years and presence of acute diarrhea defined as the occurrence of >3 stools per day graded as 6 or 7 on the Bristol scale [11, 12]
Summary
There is a strong rationale for the use of agents with film-forming protective properties, like xyloglucan, for the treatment of acute diarrhea. According to the World Health Organization (WHO), acute diarrhea is defined as the production of three or more passages of loose or watery stools a day in a 24-h period, for less than 14 days [1, 2]. In non severe acute diarrhea of gastroenteritic origin, the stools do not contain visible amounts of blood or mucus [1]. Diarrhea is the expression of an altered homeostasis of the bowel [3], being intestinal infections (viral, bacterial and parasitic) the most common cause. After perinatal death (23 %) and acute respiratory infection (18 %), acute diarrhea represents the third cause of death (15 %) in children under the age of 5 living in developing countries [5,6,7]
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