title: Efficacy and safety of a natural mineral water rich in magnesium and sulphate for bowel function: a double-blind, randomized, placebo-controlled study.
abstract: OBJECTIVE
  The present placebo-controlled, double-blind, randomized trial aimed to investigate whether a natural mineral water rich in magnesium sulphate and sodium sulphate (Donat Mg) may help to improve bowel function.
  
  
  METHODS
  A total of 106 otherwise healthy subjects with functional constipation were randomly assigned to consume 300 or 500 mL of a natural mineral water as compared to placebo water, over a course of 6 weeks. The 300-mL arms were terminated due to the results of a planned interim analysis. Subjects documented the complete spontaneous bowel movements, spontaneous and overall bowel movements/week, stool consistency, gastrointestinal symptoms and general well-being in a diary. Change in the number of complete spontaneous bowel movements was defined as the primary outcome.
  
  
  RESULTS
  For the 75 subjects in the 500-mL arms, the change in the number of complete spontaneous bowel movements per week tended to be higher in the active group when compared to placebo after 6 weeks (T2 = 1.8; pvalue= 0.036; one-sided). The mean number of spontaneous bowel movements significantly increased over the course of the study, with significant differences between study arms considering the whole study time (F test = 4.743; ptime × group= 0.010, 2-sided). Stool consistency of spontaneous bowel movements (p < 0.001) and the subjectively perceived symptoms concerning constipation (p = 0.005) improved significantly with the natural mineral water as compared to placebo.
  
  
  CONCLUSIONS
  The daily consumption of a natural mineral water rich in magnesium sulphate and sodium sulphate improved bowel movement frequency and stool consistency in subjects with functional constipation. Moreover, the subjects' health-related quality of life improved.
  
  
  BACKGROUND
  EudraCT No 2012-005130-11.
authors.affiliation: Analyze & Realize GmbH, Waldseeweg 6, 13467, Berlin, Germany.
authors.forename: Gordana
authors.initials: G
authors.lastname: Bothe
authors.affiliation: Droga Kolinska, d.d., Kolinska ulica 1, 1544, Ljubljana, Slovenia.
authors.forename: Aljaz
authors.initials: A
authors.lastname: Coh
authors.affiliation: Analyze & Realize GmbH, Waldseeweg 6, 13467, Berlin, Germany. aauinger@a-r.com.
authors.forename: Annegret
authors.initials: A
authors.lastname: Auinger
mesh_terms: D000328:Adult; D003248:Constipation / Q000188:drug therapy* / Q000453:epidemiology; D004032:Diet; D004311:Double-Blind Method; D005243:Feces; D005260:Female; D005858:Germany / Q000453:epidemiology; D006293:Health Promotion; D006801:Humans; D008278:Magnesium Sulfate / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D008900:Mineral Waters; D010919:Placebos; D011788:Quality of Life; D013431:Sulfates / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D008900:Mineral Waters; D010919:Placebos; D013431:Sulfates; C012036:sodium sulfate; D008278:Magnesium Sulfate
keywords: Bowel function; Clinical trial; Natural mineral water; Stool frequency and consistency