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Notes: Background : Beidellitic montmorillonite is a purified clay containing a double aluminium and magnesium silicate.Aim : To assess the efficacy and the safety of beidellitic montmorillonite (3 g, t.d. for 8 weeks) in patients with irritable bowel syndrome (IBS).Methods : A multicentre, double-blind, placebo-controlled, randomized study with parallel groups, was performed in IBS patients selected according to ROME I criteria. Patients were included after a 1-week washout period to confirm that abdominal pain and/or discomfort was rated at least 2 on a 0–4 graded Likert scale. Patients were then randomized and stratified according to their predominant bowel habit profile into three groups. The use of rescue medication was allowed: polyethylene glycol 4000 (10–20 g/day) as a laxative agent in case of stool absence for three consecutive days, phloroglucinol (80 to a maximum of 320 mg/day) as a spasmolytic agent for no more than 8 days. The main end-point was the improvement of abdominal pain and/or discomfort by at least 1 point on the Likert scale.Results : A total of 524 patients constituted the overall intent-to-treat population (ITT), 263 were assessed in the beidellitic montmorillonite group, i.e. 93 diarrhoea-predominant IBS (D-IBS), 83 constipation-predominant IBS (C-IBS), 87 alternating constipation/diarrhoea-IBS (A-IBS); 261 in the placebo group, i.e. 81 D-IBS, 92 C-IBS and 88 A-IBS. Initial analysis in the ITT population demonstrated a higher rate of success with beidellitic montmorillonite (51.7%) when compared with the placebo group (45.2%); however, the difference was not statistically significant. Improvement was significant in C-IBS both in ITT (beidellitic montmorillonite group = 49.4%, placebo group = 31.5%, P 〈 0.016) and per protocol populations (59.4% vs. 37.8%) (P 〈 0.01). The time to improvement of abdominal pain and/or discomfort (log Rank test) was also significantly in favour of beidellitic montmorillonite, (P 〈 0.04). The average number of stools per day was not different from baseline, either in all patients or in C-IBS patients. Spasmolytic and laxative agent intakes were not different between the two groups. Subjective evaluation by patients of treatment efficacy and visual analogue scale test of treatment efficacy by investigators were significantly better in the beidellitic montmorillonite group (P 〈 0.05). Tolerance of beidellitic montmorillonite was considered optimal without any significant adverse event.Conclusions : Although pain or discomfort was not significantly improved in the entire IBS population treated with beidellitic montmorillonite in comparison with placebo, this study demonstrates that beidellitic montmorillonite is efficient for C-IBS patients (P 〈 0.016). This effect of beidellitic montmorillonite on pain cannot be explained by changes in bowel habits. The efficacy of this well-tolerated therapy warrants further confirmatory therapeutic trials in C-IBS patients.

Notes: Background : Impedance-pH monitoring is the most sensitive method for detection and characterization of gastro-oesophageal reflux episodes. Normal values from European subjects are lacking.Aim : To build a database of gastro-oesophageal reflux patterns from French and Belgian healthy subjects.Methods : Seventy-two healthy subjects (35 men, mean age 35 years, 18–72) underwent 24-h ambulatory impedance-pH studies. Gastro-oesophageal reflux episodes were detected using impedance and characterized by pH as acid, weakly acidic, or weakly alkaline. Analysis was performed visually and effects of age, gender and intra-individual reproducibility were evaluated.Results : The total number of gastro-oesophageal reflux episodes was 44 (25,58,75) of which 59% were acid, 28% were weakly acidic and 10% weakly alkaline. Half of gastro-oesophageal reflux episodes were mixed (liquid/gas) and 22% reached 15 cm above the lower oesophageal sphincter. The bolus clearance time was 11 s while acid was chemically cleared in 34 s. Male gender was associated with increased number and proximal extent of total and acid gastro-oesophageal reflux. Repeated studies in 27 subjects showed good reproducibility for number, acidity and air–liquid composition of reflux (Kendall's W-values = 0.72–0.85).Conclusions : This study demonstrates good reproducibility of 24-h ambulatory impedance-pH studies and provides values of reflux patterns in healthy subjects for comparisons with European gastro-oesophageal reflux disease patients.