BACKGROUND: There is a strong rationale for the use of agents with film-forming protective properties, like xyloglucan, for the treatment of acute @entity294 . However, few data from clinical trials are available. METHODS: A randomized, controlled, open-label, parallel group, multicentre, clinical trial was performed to evaluate the efficacy and safety of xyloglucan, in comparison with @entity35003 and @entity375 in adult @entity1 with acute @entity294 due to different causes. @entity1 were randomized to receive a 3-day treatment. Symptoms (stools type, @entity390 , @entity391 , @entity490 and @entity11634 ) 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. RESULTS: A total of 150 @entity1 (69.3  % @entity1 and 30.7  % @entity1 , 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 @entity35003 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 @entity35003 (p   =   0.031). Xyloglucan was the most efficient treatment in reducing the percentage of @entity1 with @entity390 throughout the study period, particularly during the first hours (from 26  % at baseline to 4  % after 6 and 12  h). An important improvement of @entity391 was observed in all three treatment groups. Xyloglucan was more effective than @entity35003 and S. bouliardii in reducing @entity490 , with a constant improvement observed throughout the study. The clinical evolution of @entity11634 followed similar patterns in the three groups, with continuous improvement of the symptom. All treatments were well tolerated, without reported adverse events. CONCLUSIONS: Xyloglucan is a fast, efficacious and safe option for the treatment of acute @entity294 . TRIAL REGISTRATION: EudraCT number 2014-001814-24 (date: 2014-04-28) ISRCTN number: 90311828.

Xyloglucan for the treatment of acute XXXX : results of a randomized, controlled, open-label, parallel group, multicentre, national clinical trial.

@entity1 :: ('9606', 'Species') :: ['women', 'Patients', 'patients', 'men'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity11634 :: ('MESH:D005414', 'Disease') :: ['flatulence'] @entity490 :: ('MESH:D015746', 'Disease') :: ['abdominal pain'] @entity375 :: ('4932', 'Species') :: ['Saccharomyces'] @entity35003 :: ('MESH:C033214', 'Chemical') :: ['diosmectite']
@entity294 :: (MESH:D003967,Disease) :: ['diarrhea']
