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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Guarino A, Lo Vecchio A, Pirozzi MR. Clinical role of diosmectite in the management of diarrhea. Expert Opin Drug Metab Toxicol. 2009;5:433–40. Fairbrother SE, Smith JE, Borman RA, Cox HM. EP4 receptors mediate prostaglandin E2, tumour necrosis factor alpha and interleukin 1beta-induced ion secretion in human and mouse colon mucosa. Eur J Pharmacol. 2012;694:89–97. 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.

Diosmectite (brand names Smecta, Smecdral) is a natural silicate of aluminium and magnesium used as an intestinal adsorbent in the treatment of several gastrointestinal diseases, including infectious and non-infectious acute and chronic diarrhoea, including irritable bowel syndrome diarrhea subtype. Other uses include: chronic diarrhea caused by radiation-induced, chemotherapy-induced, and HIV/AIDS-associated chronic diarrhea. [1] Yao-Zong Y, Shi-Rong L, Delvaux M. Comparative efficacy of dioctahedral smectite (Smecta) and a probiotic preparation in chronic functional diarrhoea. Dig liver Dis Off J Ital Soc Gastroenterol Ital Assoc Study Liver. 2004;36:824–8 Netherlands. Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, et al. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013;500:541–6 England. 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). Clark KJ, Sarr AB, Grant PG, Phillips TD, Woode GN. In vitro studies on the use of clay, clay minerals and charcoal to adsorb bovine rotavirus and bovine coronavirus. Vet Microbiol. 1998;63:137–46.

Diosmectite

We further looked for diosmectite impact at the species level. Considering the 450 MGS that were present in more than 10% of samples, the AUC analysis showed that 18 MGS had a different evolution before and after treatment ( p ≤ 0.05, Wilcoxon signed-rank test). Among them, only 4 and 5 MGS had a significantly different abundance in at least one of the three time points before treatment or during treatment, respectively (p ≤ 0.05, Friedman test). The five MGS whose abundance changed during the treatment had low prevalence at D-1 (32% ± 0.1, see Additional file 1, Supplementary Fig. 2) and accounted for only 0.3% ± 0.5 of the total microbiota. Moreover, we found the same number of MGS ( n = 35) whose abundance changed significantly before the treatment (at D-30, D-14 or D-1, Friedman test, p ≤ 0.05), or during the treatment (at D-1, D8, D35, Friedman test, p ≤ 0.05), suggesting even more random variations instead of an effect of the treatment. Additionally, after correction for multiple testing only one MGS was significantly altered before the treatment, and none during the treatment. Despite significantly shorter time to recovery in the diosmectite group, the proportions of patients achieving recovery were similar in both groups at the end of the study. This is explained by acute watery diarrhoea being self-resolving within seven days. RV-induced diarrhoea is the result of multiple combined mechanisms. RV targets mature enterocytes, altering the villous structure and inducing disaccharidase loss and carbohydrate malabsorption. It damages tight junction structure and impairs the barrier function of intestinal epithelial cells, allowing RV to access the basolateral side of the enterocyte [ 17]. Flow chart of study populations. Diosmectite (6g three times a day) or placebo in the treatment of acute diarrhoea in adults.

P-value correspond to Mann–Whitney test for quantitative variables (age, Bristol scale, MGS richness), and for Chi-squared test for categorical variables (sex, country expressed as Great Britain percentage). Quantitative values are displayed as mean±standard deviation

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. R Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria; 2017. Available from: https://www.r-project.org/ Aguzzi C, Cerezo P, Viseras C, Caramella C. Use of clays as drug delivery systems: possibilities and limitations. Appl Clay Sci. 2007;36:22–36. Available from: http://www.sciencedirect.com/science/article/pii/S0169131706001505). The subjects were treated with diosmectite (Smecta® 3 g/sachet, powder for oral suspension, Ipsen, France). It consisted in three sachets per day (TID), administrated at morning, noon, and evening. Subjects were instructed to take diosmectite fasting and at least one hour before meal, except for breakfast at least ½ hour before. Study design



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