The Effect of a Multi-strain Probiotic on the Symptoms and Small Intestinal Bacterial Overgrowth in Constipation-predominant Irritable Bowel Syndrome: A Randomized, Simple-blind, Placebo-controlled Trial

Abstract

Background and aim: the qualitative and quantitative difference in the intestinal microbiota between irritable bowel syndrome (IBS) patients and healthy volunteers doesn't raise doubts. Small intestinal bacterial overgrowth(SIBO), reported in 9-35% patients with constipation-predominant of irritable bowel syndrome (IBS-C), is involved in the pathogenesis IBS. Elimination of SIBO can lead to improvement of clinical symptoms. The aim of this study was to assess the efficacy of a bifido- and lactobacillis-containing probiotic Florasan-D on the eradicating SIBO and on the severity of clinical symptoms in patients with IBS-C. Methods: this randomized (1 : 1), simple-blinded, placebo-controlled investigation conducted at one centre in Russia.33 patients with IBS-C (clinical type was determined according to ROME III criteria) were randomized to receive a multi-strainprobiotic Florasan-D containing Bifidobacteriumbifidum, Bifidobacteriumlongum, Bifidobacteriuminfantis, Lactobacillus rhamnosus or placebo for 4 weeks: 16 and 17 persons respectively. The intensity of abdominal pain and bloating was estimated by a visual analogue scale (VAS), stool consistency – by a Bristol stool form scale before and after the intervention. Quality of life was assessed by the Short Form-36 questionnaire (SF-36). All subjects were analysed by lactulose hydrogen breath test with using Gastro+ Gastrolyzer (Bedfont, UK) to determine SIBO. Results: patients treated with multi-strainprobiotic Florasan-D reported a reduction in the severity of clinical symptoms: abdominal pain decreased from 4 to 2 point (р=0,003), stool frequency – from 3 to 7 per week (р=0,001) and stoolconsistency – from type 2 to type 3 by a Bristol stool form scale (р=0,001); SIBO was found in 56,3% patients before treatment and no patients had this syndrome after therapy. Patients treated with placebo reported a reduction the severity of abdominal pain only (р=0,028). SIBO in these patients before treatment was revealed in 52,9% and remained in all patients after it. Conclusions: multi-strainprobiotic Florasan-D is significantly more effective than placebo for reduction of clinical symptoms and SIBO elimination in IBS-C patients.