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.
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.
The presentation of blood collection management in Romania, is structured in 4 parts: the first part is devoted to general presentation of organization of National Network, with afferent legislation and regulations; the second one displays certain social-economic and demographic data, such as ageing/gender, gross domestic product, and unemployment rate, aiming to have a general view about Romanian historical, current and forecasted data, each of them being partly involved in future national strategy in transfusion field. The third part refers to certain interconditioned situations, which fingerprint the national policy regarding quality system in transfusion field, represented by: -general population evolution in terms of impact upon donors' poolhaving as references: the total number of donations, and donations/1000 inhabitantshistorical data and forecast for the next 6 years; -an approach of identification of the most reliable and safer potential blood donors' groups, by displaying the evolution of first time donations, according to period of time, number, age, gender; -"meet of demand" with explanation of the existing huge gap; -the complexity of specific activity in collection/processing, refering to: number of collected units/separation rate of total blood, and number of platelets apheresis procedures, and testing regarding the total number of laboratory tests, aiming the maximum security for transfusion therapy; -taken into account the evolution of medical staff, at to both levels: national and transfusion network, with obvious evidence of undersized in number and overloaded in job description. Based on the above objective parameters, and on EC missions conclusions, with the interest of drawing the future policies in transfusion field, the fourth part presents a questionnaire designed for fraiming each blood establishment, regarding blood donation promotion, and blood donors recruitment, operational marketing in blood donation process, blood supply management, and blood collection activity; the answers were interpreted according to a predetermined evaluation scale about strategies: short-, medium-and long term /degrees of priority, and actions: presence, number and efficiency. Further, were selected and displayed part of the answers to above mentioned criteria, with concurrent SWOT analyse, and afferent codification for future national policy. Some pertinent conclusions arose, about the correlation of human resources (number and training) with: acquisition of modern equipment, use of an unique computerized soft for recruitment and retention activities, and hemovigillance purpose, standardized reporting system, authorized vehicles for mobile collections, and renovation and modernization of the infrastructures, all of these based on performance criteria/blood collection management, thus security requirement and satisfaction of the medical staff (prehospital and hospital), blood donors and recipients, being fulfilled, as major objective of national policy.
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