Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial.

Background: Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape seed extract, and xylo-oligosaccharides (XOS), which act together to protect and reinforce the intestinal barrier. Objective: The objective of this study is to evaluate the efficacy and safety of XG + PPT + XOS in patients with diarrhoea-predominant IBS (IBS-D). Methods: In this double-blind study, 60 patients were randomly assigned to receive XG + PPT + XOS or placebo for 28 days, then crossed over to the alternative treatment. Patients were followed for 60 days. Results: At Day 28, a significantly higher proportion of patients starting treatment with XG + PPT + XOS than placebo (87 vs 0%; p = 0.0019) presented normal stools (Bristol Stool Form Scale type 3-4). At Day 56, a significantly higher proportion of patients who crossed over to XG + PPT + XOS than placebo (93% vs 23%; p = 0.0001) presented normal stools. In the group allocated to receive XG + PPT + XOS after placebo, benefits of XG + PPT + XOS were maintained during follow-up. Subjective assessments of abdominal pain, bloating, quality of life and general health indicated significant improvement with XG + PPT + XOS over placebo. There were no related adverse events. Conclusion: XG + PPT + XOS effectively controlled diarrhoea and alleviated clinical symptoms in patients with IBS-D, and was well tolerated.

Atherosclerosis Burden and Therapeutic Challenges Regarding Acute Coronary Syndromes in Chronic Kidney Disease Patients.

The major cause of death in patients with chronic kidney disease is represented by cardiovascular events. Atherosclerosis is usually initiated by the association of traditional and non-traditional risk factors, and the acute thrombotic complications are more frequent in subjects with reduced glomerular filtration rate. The diagnosis of acute coronary syndromes is challenging due to the increased values of cardiac necrosis enzymes correlated with reduced renal function.

Efficacy and safety of APT036 versus simethicone in the treatment of functional bloating: a multicentre, randomised, double-blind, parallel group, clinical study.

BACKGROUND: Bloating is a common symptom reported by around 16% to 31% of the general population. Functional bloating is diagnosed in patients with recurrent symptoms of bloating who do not meet the diagnostic criteria of irritable bowel syndrome or other functional gastrointestinal disorders. METHODS: This double-blind, multicentre, randomised study compared the safety and efficacy of APT036 (xyloglucan plus tyndallized Lactobacillus reuteri and Bifidobacterium brevis; Aprotecol®) and simethicone in treating functional bloating in adults. APT036 or simethicone were administered orally (3 times/day) for 20 consecutive days, with evaluations at baseline, and on Days 2, 10, 20 (end of treatment) and 30 (follow-up visit). The main outcome measure was safety. Efficacy was assessed at each visit by patient-reported symptom severity (Likert scale) and abdominal girth measurement. A hydrogen breath test was performed at baseline and Day 20. RESULTS: Both APT036 (n=54) and simethicone (n=54) were well tolerated by study subjects; no adverse effects were reported with either treatment. Compared with simethicone, APT036 significantly reduced abdominal distension (P=0.008) and flatulence (P=0.010) from baseline to Day 30. The baseline hydrogen breath test confirmed the presence of small intestinal bacterial overgrowth (SIBO) in all subjects. At Day 20, mean hydrogen gas elevation was below the threshold for a diagnosis of SIBO (<12 ppm above basal on glucose administration) in both study arms. CONCLUSIONS: Both APT036 and simethicone had good safety profiles but APT036 was superior to simethicone in relieving symptoms of functional bloating.