title: A randomized double-blind placebo-controlled clinical trial on efficacy and safety of association of simethicone and Bacillus coagulans (Colinox®) in patients with irritable bowel syndrome.
abstract: BACKGROUND
  Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects 15-20% of the Western population.
  
  
  BACKGROUND
  There are currently few therapeutic options available for the treatment of IBS. The aim of this study is to evaluate the efficacy and the safety of a medical device containing a combination of Simethicone and Bacillus coagulans in the treatment of IBS.
  
  
  METHODS
  This is a monocentric double-blind, placebo-controlled parallel group clinical trial. Adult subjects suffering from IBS as defined by Rome III criteria were enrolled. Bloating, discomfort, abdominal pain were assessed as primary end point. Subjects received the active treatment or placebo 3 time a day after each meal for 4 weeks of study period. Subjects were submitted to visit at Day 0 (T1), at Days 14 (T2) and 29 (T3).
  
  
  RESULTS
  Fifty-two patients were included into the study. Intragroup analysis showed a significant reduction of the bloating, discomfort and pain in Colinox® group (CG) compared to placebo group (PG). Between group analysis confirmed, at T1-T3, significant differences between CG and PG in bloating and discomfort.
  
  
  CONCLUSIONS
  Simethicone is an inert antifoaming able to reduce bloating, abdominal discomfort. Literature offers increasing evidence linking alterations in the gastrointestinal microbiota and IBS and it is well known that probiotics are important to restore the native gut microbiota. The Colinox medical device is specifically targeted against most intrusive symptom of IBS (bloating) and it is also able to counteract the most accredited ethiopathogenetic factor in IBS (alterations of intestinal microbiota).
  
  
  CONCLUSIONS
  This is the first randomized double-blind placebo-controlled clinical trial demonstrating the efficacy and safety of a combination of simethicone and Bacillus coagulans in treatment of IBS.
authors.affiliation: Department of Internal Medicine and Gastroenterology, Complesso Integrato Columbus, Catholic University of the Sacred Heart, School of Medicine, Rome, Italy. riurgesi@tin.it.
authors.forename: R
authors.initials: R
authors.lastname: Urgesi
authors.forename: C
authors.initials: C
authors.lastname: Casale
authors.forename: R
authors.initials: R
authors.lastname: Pistelli
authors.forename: G L
authors.initials: GL
authors.lastname: Rapaccini
authors.forename: I
authors.initials: I
authors.lastname: de Vitis
mesh_terms: D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control; D000328:Adult; D000368:Aged; D000934:Antifoaming Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001407:Bacillus / Q000145:classification / Q000254:growth & development*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007422:Intestines / Q000187:drug effects* / Q000382:microbiology*; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000175:diagnosis / Q000382:microbiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D012384:Rome; D012841:Simethicone / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000934:Antifoaming Agents; D012841:Simethicone