Open AccessThe combination of oligo‐ and polysaccharides and reticulated protein for the control of symptoms in patients with irritable bowel syndrome: Results of a randomised, placebo‐controlled, double‐blind, parallel group, multicentre clinical trial
Author(s) -
Alexea Octavian,
Bacarea Vlad,
Piqué Núria
Publication year - 2016
Publication title -
ueg journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.667
H-Index - 35
eISSN - 2050-6414
pISSN - 2050-6406
DOI - 10.1177/2050640615615050
Subject(s) - medicine , flatulence , irritable bowel syndrome , placebo , bloating , clinical endpoint , abdominal pain , clinical trial , gastroenterology , quality of life (healthcare) , placebo controlled study , double blind , pathology , alternative medicine , nursing
Background A medical device containing the film‐forming agent reticulated protein and a prebiotic mixture of vegetable oligo‐ and polysaccharides has been developed, recently receiving European approval as MED class III for the treatment of chronic/functional or recidivant diarrhoea due to different causes including irritable bowel syndrome (IBS). In the present paper, we evaluate a protein preparation containing these components in comparison with placebo in adult patients with diarrhoea‐predominant IBS. Methods In a randomised, placebo‐controlled, double‐blind, parallel group, multicentre clinical trial, patients were randomly assigned to receive the combination of oligo‐ and polysaccharides and reticulated protein and placebo (four oral tablets/day for 56 days). Demographic, clinical and quality of life characteristics and presence and intensity of abdominal pain and flatulence (seven‐point Likert scale) were assessed at three study visits (baseline and at 28 and 56 days). Stool emissions were recorded on the diary card using the seven‐point Bristol Stool Scale. Results A total of 128 patients were randomised to receive either tablets containing the combination ( n = 63) or placebo ( n = 65). Treatment with oligo‐ and polysaccharides and reticulated protein was safe and well tolerated. A significant improvement in symptoms across the study was observed in patients treated with oligo‐ and polysaccharides and reticulated protein between visit 2 and visit 3 in abdominal pain ( p = 0.0167) and flatulence ( p = 0.0373). We also detected a statistically significant increase in the quality of life of patients receiving the active treatment from baseline to visit 3 ( p < 0.0001). Conclusions Treatment with oligo‐ and polysaccharides and reticulated protein is safe, improving IBS symptoms and quality of life of patients with diarrhoea‐predominant IBS.