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

BMC Gastroenterology

Núria Piqué¹  Marius Marusteri³  Vladimir Bacarea⁴  Lucio Gnessi² 

[1]Department of Microbiology and Parasitology, Pharmacy Faculty, Universitat de Barcelona, Diagonal Sud, Facultat de Farmàcia, Edifici A, Av Joan XXIII, Barcelona, 08028, Spain

[2]Department of Experimental Medicine, University of Rome “La Sapienza”, Rome, 00161, Italy

[3]Department of Medical Informatics and Biostatistics, University of Medicine & Pharmacy, Targu-Mures, Romania

[4]Department of Epidemiology, University of Medicine & Pharmacy, Targu-Mures, Romania

关键词: Vomiting;    Abdominal pain;    Stools;    Mucosal protectors;    Xyloglucan;    Gelatin;    Onset of action;    Safety;    Efficacy;    Acute diarrhea;   

Others  :  1234292
DOI  :  10.1186/s12876-015-0386-z

 received in 2015-02-25, accepted in 2015-10-22,  发布年份 2015

【 摘 要 】

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

【 授权许可】

   
2015 Gnessi et al.

【 图 表 】

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