Assessment of elemental impurities level after taking Diosmectite
Research type
Research Study
Full title
Assessment of Elemental Impurities Level after Chronic Administration of Diosmectite (Smecta®) in Subjects with Chronic Diarrhoea
IRAS ID
212203
Contact name
Nick Probert
Contact email
Sponsor organisation
Aepodia France S.A.R.L
Eudract number
2016-002111-18
Duration of Study in the UK
0 years, 8 months, 30 days
Research summary
SMECTA® is indicated in the treatment of diarrhoea and is a natural clay extracted from geological deposits specially selected for their high quality. The compound is marketed in more than 70 countries for the following indications: the treatment of acute diarrhoea in children (including infants), the treatment of acute diarrhoea in adults, the symptomatic treatment of chronic functional diarrhoea in adults and the symptomatic treatment of pain associated with functional bowel diseases in adults. \nThe main purpose of this study is to assess the levels of certain metals in the blood after standard doses of the study compound in patients with chronic diarrhoea. \n
REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0433
Date of REC Opinion
30 Aug 2016
REC opinion
Favourable Opinion