• Clinical studies

    In vitro and In-vivo experiments have shown that, unlike other clay bulk forming agents that mainly bind water, diosmectite can also bind viruses and bacterial toxins and suppresses cytokine-induced intestinal inflammation. The clinical efficacy of diosmectite to reduce diarrhoea duration has been proven in several clinical trials (ref: Acute Infectious Diarrhoea in Children – The Role of Drug Treatment, Eduardo Salazar – Lindo, Motility Disorders, 2011, 31-36)

    Apical effect of diosmectite on damage to the intestinal baffler induced by basal tumour necrosis factor-cx, L Mahraoui, Gut 1997; 40: 339-343

    • Basal TNFα disrupts the intestinal barrier through the tight junctions, and apical diosmectite counteracts this disruption.
    • Diosmectite alone did not alter epithelial permeability and fully restored the barrier properties of the epithelial layer after disruption of the layer by TNFα.
    • In conclusion, the present results suggest that diosmectite may reduce the consequences of intestinal inflammation by acting from the luminal side of the epithelium.

    European Society for Pediatric Gastroenterology, Hepatology, and Nutrition/European Society for Pediatric Infectious Diseases Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe: Update 2014. Guarino, Alfredo (Coordinator), Journal of Pediatric Gastroenterology & Nutrition: July 2014 – Volume 59 – Issue 1 – p 132–152

    These guidelines update and extend evidence-based indications .for the management of children with acute gastroenteritis in Europe.

    In conclusions, Effective interventions include administration of specific probiotics such as Lactobacillus GG or Saccharomyces boulardii, diosmectite or racecadotril.

    Among the non recommended interventions are Loperamide, Bismuth subsalicylate or other absorbents (namely, kaolin–pectin and attapulgite-activated charcoal).

    The 72 hour cumulative stool output was lower and diarrhea duration shorter in the diosmectite group than in the placebo group. The positive effect of diosmectite was confirmed in both rotavirus-positive and rotavirus-negative children.

    A more recent open RCT carried out in India also found that diosmectite reduced the duration of diarrhea and prevented pro-longed course. The time for resolution of the diarrhea was significantly shorter as was the total duration of diarrhea in the diosmectite group than in the control group.

     

    Smectite in Acute Diarrhea in Children: A Double Blind Placebo-Controlled Clinical Trial, Ahmed A. Madkour, Journal of Pediatric Gastroentology and Nutrition, 1993, Raven Press Ltd, New York, 17: 176-181

    It can be concluded that dioctahedral smectite exerts a beneficial effect in shortening the duration of diarrhoea, reducing the frequency of liquid stools and enhancing weight gain in children with acute diarrhoea rehydrated with ORS. The drug is acceptable, safe, and well tolerated and did not interfere with ORT and normal feeding. The same conclusions were reached by the WHO committee on diarrhoeal disease (30), although the committee was not in favour of recommending DS use in view of the additional cost when oral rehydration therapy is by itself lifesaving. However, we believe that cost is more than offset by the reduction in the duration of diarrhoea, in the time spent by the parents to take care of their children, and in the length of hospital stay.

    Acute Infectious Diarrhoea in Children – The Role of Drug Treatment, Eduardo Salazar – Lindo, Motility Disorders, 2011, 31-36

    Diosmectite is a naturally occurring multilameller clay silicate with strong binding properties. In vitro or in vivo experiments have shown that unlike other clay bulk-forming agents that mainly bind water, diosmectite can also bind viruses and bacteria toxins and supresses cytokine-induced intestinal inflammation. The clinical efficacy of diosmectite to reduce diarrhoea duration has been proven in several clinical trials. More recently, two multicentre, double blind, placebo controlled trials involving 602 children with acute diarrhoea and dehydration in peru and Malaysia have shown that diosmectite significantly reduces both duration of diarrhoea and stool volume, and has been found to be safe and well tolerated.

    Oral Diosmectite reduces stool output and diarrhoea duration in children with acute watery diarrhoea, Christophe Dupont, Clinical Gastroenterology and Hepatology, 2009, 456-462

    • The presence studies showed that Diosmectite used as an adjunct therapy to the ORS currently recommend by the World Health Organisation decreased 72h hours stool output in children, particularly if rotavirus positive and shortens the duration of acute watery diarrhoea.
    • Diosmectite adsorbs bacteria, viruses and bacterial toxins, has a covering effect and interacts with intestines, has a protective effect against intestinal inflammation induce by tumor necrosis factor-alpha, and has shown previously Diosmectite increases the absorptive capacity of the intestinal mucosa.
    • In 1985, Edelman stated the characteristics of the ideal antisecretory compound for the treatment of infectious diarrhoea: inhibits fluid secretion or stimulates fluid absorptions by intestinal mucosa, onset action within minutes, limited constipation affect, high therapeutic index, non-interference with recovery of local bowel function, minimal central nervous system effects, low abuse potential and low cost. These appear to be globally met by Diosmectite in terms of both efficacy and safety.

    Role of Antidiarrheal drugs as adjunctive therapies for Acute Diarrhoea in Children, Christopher Faure, 1-14, and 2013

    • Diosmectite is eliminated unchanged directly through the faeces within sixteen hours of administration
    • Diosmectite can adsorb bacterial toxins, bacteria, viruses, bile salts and lysolecithins.
    • Due to its multilayer structure and its high plastic viscosity, Diosmectite possess powerful coating properties.
    • Diosmectite has been demonstrated to supress the production of cytokines such as interleukin-8 from secretory epithelial cells.

    Efficiency of dioctahedral smectite in treating patients of diarrhoea-predominant irritable bowel syndrome, Full-Young Chang & Ching-Liang Lu & Chih-Yen Chen and Jiing-Chyuan Luo, 217-227, 2007

    A Meta-analysis of data from RCTs showed that in children with acute infectious gastroenteritis, smectite compared with the control is associated with a moderate reduction in the duration of diarrhoea.

    Management of Lithuanian Children’s Acute Diarrhoea With Gastrolit Solution And Dioctahedral Smectite, Irena Narkevicuite And Odilija Rudzeviciene And Giedra Levinine And Kristina Mociskiene And Rimantas Eidukevicius, 419-424, 2002

    • The drug adsorbs agents aggressing the intestinal mucosa, including rotavirus, E.coli and campylobacter
    • Diosmectite can decrease the percentage of children with persistent diarrhoea, and it has no bad side effects
    • The Diosmectite solution stopped children’s duration of hospitalisation by 0.4 compared to solutions without Diosmectite.
    • Only 3% of 54 children still has diarrhoea on day 5 after using Diosmectite solutions

    Treatment of acute diarrhoea in adults with dioctahedral smectite (Smecta): a prospective randomised study, KH Cheung and WL Yuen, Hong Kong Journal of Medicine vol13(2) 2006, 85-89

    • Is the most commonly prescribed anti-diarrhoeal drug in some accident and emergency departments and in general practice
    • It interacts with mucus molecules, strengthens mucosal barrier and protects the apical poles of enterocytes and the tight junctions against bacteria and toxins, bacteria and rotavirus.
    • In regards to side effects of Smecta, there were no adverse effects demonstrated.
    • The safety profile of Diosmectite may be better than loperamide and diphenoxylate

    Anti-diarrheal effects of diosmectite in the treatment of acute diarrhoea in children A Review, Christophe Dupont and Bernard Vernisse, Pediatr. Drugs 2009, 11 (2) 89-99

    • Adsorbent properties and anti-inflammatory activity in both in-vivo and in-vitro studies. There are several mechanism by which diosmectite can treat diarrhoea.
    • Reduces inflammation
    • Can bind the mucus barrier and alter its rheological properties, inhibiting mucolysis and increasing colonic mucin.
    • Adsorb toxins and other compounds, including bacterial enterotoxins and viruses
    • Enhances the absorptive capability of the gut in-vivo
    • Significantly reduces stool output in children with mild to moderate acute diarrhoea
    • Lack of systemic absorption
    • Well tolerate, even by very young children
    • Can be administered as an adjunct to ORT without affecting its absorption or efficacy

     

    Full clinical studies are available on request