A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life

Purpose The aim of this study is to test in a doubleblinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria. Background There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS. Methods This is a double-blinded, randomised placebocontrolled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief. The secondary endpoints were change in abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation). Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed. Results Sixty-four IBS patients (symbiotic n032, 64 % females, mean age 38.7±12.6 years) were studied. This symbiotic mixture reduced flatulence over a 4-week period of treatment (repeated-measures analysis of covariance, p<0.05). Proportions of responders were not significantly different between groups. At the end of the treatment, a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group. Conclusions This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients, a lack of adverse events and a good side-effect profile; however, it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating. Further studies are warranted

Colonic gas transit and effects of mechanical stimulation on the abdominal wall

OC3.07.5 COLONIC GAS TRANSIT AND EFFECTS OF MECHANICAL STIMULATION ON THE ABDOMINALWALL F. Tremolaterra ∗ , A. Pascariello, D. Consalvo, C. Ciacci, P. Iovino Università Federico II, Napoli Background and aim: Bloating and abdominal distension are frequently reported by patients with functional gastrointestinal disease. Recently it has been suggested that patients with bloating have impaired intestinal handling of gas loads. Aims of our work is study the colon gas handling in irritable bowel syndrome (IBS) and functional bloating (FB) patients by a specific gas challenge test and to evaluate the effects on colon gas transit and bloating symptoms of mechanical stimulation on the abdominal wall. Material and methods: Fifteen patients (12 F, range 27-64y; 11 IBS, 4 FB) and 5 healthy control (4 F, range 20-40y) were assigned, in random order, to study I: colonic gas load (5 patients and 5 healthy control) or study II: colonic gas load + electro-mechanical stimulation of abdominal wall, active and sham (5 patients active and 5 sham). Colonic gas load study was performed by a 60 min continuous gas mixture infusion (N2, CO2, O2 in venous proportion) at 24 ml/min and by its collecting, for other 30 min, via the anal balloon-catheter. The mechanical stimulation on the abdomen was performed by an electro-mechanical stimulator (Free-lax, ADM, Israel) and was applied at active group during evacuation period of the study II. Symptom perception and abdominal distension were measured by a validated questionnaire and a metric belt-tape assembly respectively. Gas retention was calculated as the difference between the volume of gas infused and the volume of gas recovered. Results: Study I: patients developed significantly more gas retention compared to healthy control (586±50ml vs 493±41ml, p=0.01). Further the patients complained a significant more abdominal perception then healthy control either to the end infusion period (60° min) or to the end gas evacuation period (90° min) (4.5±1.0 vs 2.4±0.9 e 1.1±1.0 vs 0±0, p=0.01 e p=0.04, respectively) and more abdominal distension to the end of gas evacuation period (2.4±1.1mm vs 0.2±0.4mm, respectively; p=0.004). Study II: no statistically differences was found in gas retention, perception and abdominal distension, in all study period, among patients with or without electro-mechanical stimulation. Conclusions: Our study shows an impaired transit and tolerance of colonic gas loads in IBS and FB patients not modified by mechanical stimulation of abdominal wall. # M. Functional disorders 2. IB

A synbiotic mixture improves flatulence in irritable bowel syndrome

P.1.254 A SYNBIOTIC MIXTURE IMPROVES FLATULENCE IN IRRITABLE BOWEL SYNDROME C. Cappello ∗ , F. Tremolaterra, D. Consalvo, C. Ciacci, P. Iovino Policlinico Universitario Federico II, Napoli, Italy Background and aim: Recent data suggest that the intestinal microbiota might play a role in the pathogenesis of irritable bowel syndrome (IBS) A recent metanalysis showed that probiotics reduce symptoms of IBS in adults, according to individual strains.The aim of this study was to test the efficacy of a commercially available synbiotic mixture which contains a concentrations of a range of bacteria (5×109 Lactobacillus plantarum, 2×109 L. casei and L. gasseri, 1×109 Bifidobacterium infantis and B. longum, 1×109 L.sporogenes, 1×109, L. acidophilus and L. salivarus, 5×109 Streptococcus termophilus, and as well as inuline (beneo synergy) as a prebiotic in patients with Rome III IBS. Material and methods: A double-blind, randomized placebo-control clinical trial of the synbiotic mixture (5g BID) vs. placebo over 4-weeks after a 2 weeks run-in period. Primary endpoints: global satisfactory relief of abdominal flatulence and bloating; Patients who reported at least 50% of the weeks of treatment with satisfactory relief were designated as responders. Secondary endpoints: Change in GI symptoms (abdominal pain, flatulence, bloating and urgency) on 100 mm of VAS scales, in stool frequency and bowel functions on validated adjectival scales and in quality of life (SF36). Pre- and post-treatment total and segmental colonic transit time was assessed according to Metcalf et Al. A strict exclusion of concomitant medications that could interfere with the study was requested. Results: 64 IBS patients (synbiotic n=32, 64% females, mean age 38.7±12.6 years) completed the treatment period. Proportions of responders for satisfactory relief of flatulence and bloating were not significantly different between synbiotic and placebo group. Treatment with the synbiotic was associated with reduced flatulence (ANCOVA, p&lt;0.05). Quality of life significantly improved in all scale but the vitality in the synbiotic group, while in the placebo group the significance was reached only in role physical, bodily pain and mental health. No other significantly differences were disclosed in any endpoints, in total and segmental colonic transit measurements between groups. Conclusions: This synbiotic mixture improves flatulence score in patients with IBS. This data are in keeping with a role of intestinal bacteria in the pathophysiology of IBS

Perception of electrocutaneous stimuli in irritable bowel syndrome.

BACKGROUND Irritable bowel syndrome (IBS) and fibromyalgia syndrome (FMS) are common conditions with some AND AIM: similarities, but different perceptual responses to somatic and visceral stimuli. The purpose of this study was to assess in a large group of IBS patients the somatic perception by transcutaneous electrical nerve stimulation (TENS) and its relation to the level of severity and presence of FMS. METHODS: In 99 patients grouped by the validated functional bowel disorder severity index (FBDSI) in mild, moderate, and severe IBS and in 33 healthy controls (HC), we studied discomfort thresholds and perception of somatic stimuli at control (hands and elbows) and active (trapezius) sites by TENS and by using a specific questionnaire. RESULTS: The use of TENS showed that IBS showed significant higher thresholds and lower perception cumulative score compared to HC. The severity of IBS is significantly associated with age and mean control site values for discomfort and borderline associated with gender in the ordinal model constructed for the ascending series protocol. The severity of IBS is also significantly associated with the active cumulative perception score in the long stimulus protocol. Due to limited sample size of IBS men with FMS, analyses of discomfort thresholds and cumulative perception score by FMS were done only for women. IBS women without FMS had significantly higher mean control site values for discomfort and significantly lower active cumulative perception score than HC. IBS women with FMS had significantly lower mean active site values for discomfort thresholds than IBS women without FMS (Dunn’s test p < 0.05). CONCLUSIONS: IBS patients showed somatic hypoalgesia to electrical stimuli. The severity of IBS and the presence of FMS influence the perception of somatic stimuli induced by TENS