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 = 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.

Keywords: Irritable bowel syndrome; abdominal pain; efficacy; flatulence; mucosal protectors; quality of life; reticulated protein; stools; vegetable oligo-saccharides; vegetable polysaccharides.

Figure 1.

Study chronogram (a) and study workflow (b). AE: adverse event; IBS: irritable bowel syndrome; QoL: quality of life.

Figure 1.

Study chronogram (a) and study workflow (b). AE: adverse event; IBS: irritable bowel syndrome; QoL: quality of life.

Figure 2.

Rate of clinical remission during the study period (defined as the disappearance of diarrhoea, i.e. two or less nonwatery stools emissions per day (stool of type 5 or less on the Bristol scale).

Figure 3.

Evolution of abdominal pain and flatulence according to a seven-point Likert scale. (a) Evolution of abdominal pain in active and placebo groups from baseline to visit 3 based on a seven-point Likert scale (7 = very much better, 6 = much better, 5 = somewhat better, 4 = same, 3 = somewhat worse, 2 = much worse, 1 = very much worse). (b) Evolution of flatulence in active and placebo groups from baseline to visit 3 based on a seven-point Likert scale (7 = very much better, 6 = much better, 5 = somewhat better, 4 = same, 3 = somewhat worse, 2 = much worse, 1 = very much worse).

Figure 4.

Scores obtained in the IBS QoL questionnaire from baseline to visit 3. The IBS QoL questionnaire is a 34-item measure constructed specifically to assess the subjective well-being of patients with IBS, including eight dimensions (dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual dysfunction, and relationships). Each item is scored on a five-point scale (1 = not at all, 5 = a great deal). To facilitate score interpretation, the summed total score is transformed to a zero to 100 scale ranging from zero (maximum QoL) to 100 (minimum QoL). IBS: irritable bowel syndrome; QoL: quality of life.