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2015 ; 15
(ä): 153
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Xyloglucan for the treatment of acute diarrhea: results of a randomized,
controlled, open-label, parallel group, multicentre, national clinical trial
#MMPMID26518158
Gnessi L
; Bacarea V
; Marusteri M
; Piqué N
BMC Gastroenterol
2015[Oct]; 15
(ä): 153
PMID26518158
show ga
BACKGROUND: There 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. METHODS: A 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. RESULTS: A 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.
CONCLUSIONS: Xyloglucan is a fast, efficacious and safe option for the treatment
of acute diarrhea. TRIAL REGISTRATION: EudraCT number 2014-001814-24 (date:
2014-04-28) ISRCTN number: 90311828.