Smecta*60 Sachets. A New Step in Treating Diarrhoea -Powder for Oral Suspension.

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Smecta*60 Sachets. A New Step in Treating Diarrhoea -Powder for Oral Suspension.

Smecta*60 Sachets. A New Step in Treating Diarrhoea -Powder for Oral Suspension.

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Diosmectite is a natural aluminomagnesium silicate adsorbent clay that exerts antidiarrheal effects on the intestinal epithelium 18, 19, 20. Its effects are localized in the intestinal lumen or luminal surface of the epithelium where it adsorbs toxins, bacteria, and virus complexes 17. There is also evidence that it can counteract rotavirus-induced cytotoxic damage and ion secretion via inhibition of viral replication and expression of the non-structural viral protein NSP4 19, 21. Before the emergence of COVID-19, an in vitro evaluation of several adsorbent clays (including a range of smectites) found a high adsorption capability for coronavirus, with high affinity (0.06–3.09% desorption). The study authors noted, however, that adsorbent-bound virus complexes retained infectivity 13, lending further support to the rationale for avoiding diarrheal management approaches that delay intestinal transit time. Reactive oxygen species production was measured using DCFH-DA spectrofluorometry. After stimulation, DCFH-DA (20 µM) was added for 30 min at 37 °C in the dark. Intracellular ROS production was measured in a fluorometer (SFM 25; Kontron Instruments, Japan). For DCF fluorescence imaging, Caco-2 cells were grown on the cover glass for 3 days, fixed and permeabilized with paraformaldehyde 4% and Triton 0.2% for 30 min at 4 °C. Cells were then incubated with DCF-HA 20 µM for 30 min at 37 °C in the dark. Fluorescence images from multiple fields were obtained using a Nikon Eclipse e 80i microscopy. The images were analysed using the NiS Elements D imaging software (Nikon Instruments, Inc., NY, USA). Glutathione assay Cumulative percentages of recovered patients per 12h period. Recovery was the first formed stool followed by a nonwatery stool (primary endpoint). Diosmectite (6g three times a day) or placebo in the treatment of acute diarrhoea in adults.

Ducrotte P, Dapoigny M, Bonaz B, Siproudhis L. Symptomatic efficacy of beidellitic montmorillonite in irritable bowel syndrome: a randomized, controlled trial. Aliment Pharmacol Ther England. 2005;21:435–44. Based on Bristol stool scale assessment, we herein confirmed its clinical benefit in subjects with chronic diarrhea, with a reduction in overall BSS. The added observation made here is that the impact was all the more important when severity at baseline was more marked. Medici MC, Abelli LA, Martinelli M, Corradi D, Dodi I, Tummolo F, et al. Clinical and molecular observations of two fatal cases of rotavirus-associated enteritis in children in Italy. J Clin Microbiol. 2011;49:2733–9. Dupont C, Vernisse B. Anti-diarrheal effects of diosmectite in the treatment of acute diarrhea in children: a review. Paediatr Drugs. 2009;11:89–99. Droylefaix MT, Drouet Y, Schatz B. Sodium glycodeoxycholate and spinability of gastrointestinal mucus-protective effect of smectite. Gastroenterology. 1985;88:1369.Mahraoui L, Heyman M, Plique O, Droy-Lefaix MT, Desjeux JF. Apical effect of diosmectite on damage to the intestinal barrier induced by basal tumour necrosis factor-alpha. Gut. 1997;40:339–43. After a screening period of up to 6weeks including a baseline assessment, each subject was dosed with diosmectite TID over 5weeks (Day 1 to Day 35). Feces samples were collected at screening phase (D-30, D-14), at baseline visit (D-1), and over the treatment period (D8, D35). Collection was performed using a kit provided by INRAE using a stabilizing solution (RNAlater®; ThermoFisher Scientific, Waltham, US) (SOP05_V2 from the International Human Microbiome Standards, IHMS) [ 31] allowing samples to be preserved within 24h to 7days at room temperature before to be handled by laboratory. Fecal DNA was extracted following the SOP07_V2 from IHMS procedure [ 31, 32]. The DNA preparation was subjected to quality control using Qubit Fluorometric Quantitation (ThermoFisher Scientific, Waltham, US) and qualified using DNA size profiling on a Fragment Analyzer (Agilent Technologies, Santa Clara, US). 3 µg of high molecular weight DNA (> 10 kbp) was used to build the library. Shearing of DNA into fragments of approximately 150 bp was performed using an ultrasonicator (Covaris, Woburn, US) and DNA fragment library construction was performed using the Ion Plus Fragment Library and Ion Xpress Barcode Adapters Kits (ThermoFisher Scientific, Waltham, US). Purified and amplified DNA fragment libraries were sequenced using the Ion Proton Sequencer (ThermoFisher Scientific, Waltham, US), with a minimum of 20 million high-quality reads of 150 bp (in average) generated per library. We generated a mean of 22.3 million (± 0.8 million) reads per sample. Reads mapping With regards to the primary endpoint, statistical analysis was based on Wilcoxon's test in the intention-to-treat (ITT) population. The ITT population included randomized patients having taken the study drug at least once together with a primary endpoint that was assessable. Per-protocol (PP) population included ITT patients without major protocol deviations as defined after a blind review. PP analyses were supportive only. To assess robustness of the results, it was decided to perform post hoc analyses of primary efficacy data in ITT and PP populations using the “time to event” Gehan-Wilcoxon test, which takes into account censored data and their specific distributions with early events and late censures. Secondary efficacy analyses were conducted in the ITT population.

This is the first randomized, placebo-controlled trial prospectively comparing diosmectite to placebo for the treatment of acute diarrhoea in adults. This study showed that oral diosmectite sachet 6g three times a day significantly shortened time to recovery in the treatment of acute diarrhoea in adults. This was further supported by the results found in the PP population. This study also confirmed the good safety profile of diosmectite, as illustrated by the limited number of AEs, of which only 3 were considered drug related (constipation). Chang F-Y, Lu C-L, Chen C-Y, Luo J-C. Efficacy of dioctahedral smectite in treating patients of diarrhea-predominant irritable bowel syndrome. J Gastroenterol Hepatol Australia. 2007;22:2266–72. Diosmectite binds several bacterial and viral toxins [ 6, 7], and this has been postulated to contribute to its antidiarrhoeal effect. Clark et al. [ 8] observed that different clays absorb a bovine RV strain, but the infectivity was actually increased. The authors speculate that this unexpected phenomenon is the result of the more efficient presentation of virus by clays, supporting virus carriage into the cell by the clay, but no studies have been conducted to support this hypothesis. The increased infectivity was observed in kidney epithelial cells, but no information is available regarding the intestinal epithelium.

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Thus, minor changes were detected in the microbiota composition during diosmectite treatment. However, since these changes affected MGS with low prevalence and were similar to changes that occurred in the microbiota before treatment, they might be the results of time fluctuations rather than diosmectite impact. Gut microbiota is not related to symptoms before or during treatment Buccigrossi V, Laudiero G, Russo C, Miele E, Sofia M, Monini M, et al. Chloride secretion induced by rotavirus is oxidative stress-dependent and inhibited by Saccharomyces boulardii in human enterocytes. PLoS One. 2014;9:e99830. Overall, we did not find any relation between BSS and gut microbiota. We correlated MGS richness with BSS at each timepoint (see Additional file 1, Supplementary Fig. 4). The association was never significant ( p> 0.1, Spearman’s correlation) and had inconsistent direction. We then searched for MGS related to BSS before treatment (D-30, D-14, and D-1). Globally, 64 MGS (14%) were significantly correlated at one timepoint only, and their non-significant associations at other time points displayed inconsistent directions (see Additional file 1, Supplementary Fig. 5). Only one MGS (an unclassified Clostridiales) was significantly correlated to BSS at two different time points (D-30 and D-14, p ≤ 0.05, Spearman’s correlation), and none was associated at the three considered time points. Response to Diosmectite is not influenced by microbiota

Luan Z, Sun G, Huang Y, Yang Y, Yang R, Li C, et al. Metagenomics study reveals changes in gut microbiota in centenarians: a cohort study of hainan centenarians. Front Microbiol. 2020;11:1474. The time-course of the inhibitory effect of DS on ROS production was evaluated to determine whether it was maintained over the course of the experiment, and significant inhibition was indeed observed over the entire course of infection (Fig. 5b). To evaluate the role of antioxidant defences, we determined the levels of reduced and oxidized glutathione (GSH/GSSG ratio) in RV-infected Caco-2 cells following preincubation in the absence or presence of DS. The GSH/GSSG ratio was reduced when the virus was exposed to DS compared to controls (Fig. 5c). Effects of DS on RV-induced cytotoxic damage Primary and secondary endpoints were compared in both groups using appropriate statistical tests: Wilcoxon's test for quantitative parameters without normal distribution described by median and range; Student's t-test for quantitative parameters with normal distribution described by mean and standard deviation; Mantel-Haenszel's test, Chi-square or Fisher's test for qualitative parameters described by frequency and percentage. Fioramonti J, Droy-Lefaix MT, Buéno L. Changes in gastro-intestinal motility induced by cholera toxin and experimental osmotic diarrhoea in dogs: effects of treatment with an argillaceous compound. Digestion. 1987;36:230–7 Switzerland. Consistency of stools (recorded and rated according to BSS) and frequency were assessed over 24 h preceding the stool sample by the subject.Sayers EW, Agarwala R, Bolton EE, Brister JR, Canese K, Clark K, et al. Database resources of the National Center for Biotechnology Information. Nucleic Acids Res. 2019;47:D23–8.



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