The 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

Abstract

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 ¼ 63) or placebo (n ¼ 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 ¼ 0.0167) and flatulence (p ¼ 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.

Effect of Utipro ® (Containing Gelatin-Xyloglucan) Against Escherichia Coli Invasion of Intestinal Epithelial Cells: Results of an In Vitro Study

“…These results are also in line with those obtained in clinical trials in patients with diarrhea, in which the administration of xyloglucan for 3 days resulted in rapid improvements in diarrheal symptoms (measured as type 6 and 7 Bristol scale stools) and a reduction in the percentage of patients with nausea, vomiting and abdominal pain [18]. The beneficial effects of film-forming agents have also been demonstrated in patients with irritable bowel syndrome [28]. We consider that the recommended posology assures the required time to exert the preventive action: the device is to be taken orally as 2 capsules per day for 5 days in the case of patients who develop the first symptoms of urinary discomfort, and as 1 capsule per day for at least 15 consecutive days per month, to prevent recurrence (if necessary, the product can be taken for repeated cycles [Utipro Leaflet, Novintethical Pharma, SA, USA]).…”

American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome

“…The previous monograph identified no trials of prebiotics in IBS (4). The updated search identified one RCT (80). In this study 128 patients with IBS-D were recruited, and randomized to receive either prebiotics (derived from chicory) or placebo for 8 weeks.…”

Xyloglucan, a Plant Polymer with Barrier Protective Properties over the Mucous Membranes: An Overview

“…Currently, there is also increasing interest in the use of tannins and reticulated proteins (such as gelatin, etc.) using tannins (forming a three-dimensional complex) due to their film-forming properties [ 48 , 49 , 50 ].…”

“…The use of medical devices containing other film-forming agents, such as reticulated proteins, has also been assessed, in combination with a prebiotic mixture of vegetable oligo- and poly-saccharides, in patients with diarrhoea-predominant IBS [ 48 ].…”