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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.
Eur Rev Med Pharmacol Sci. 2014; 18(9):1344-53.ER

Abstract

INTRODUCTION

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.

PATIENTS AND 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.

DISCUSSION

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+Show Affiliations

Department of Internal Medicine and Gastroenterology, Complesso Integrato Columbus, Catholic University of the Sacred Heart, School of Medicine, Rome, Italy. riurgesi@tin.it.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24867512

Citation

Urgesi, R, et al. "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." European Review for Medical and Pharmacological Sciences, vol. 18, no. 9, 2014, pp. 1344-53.
Urgesi R, Casale C, Pistelli R, et al. 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. Eur Rev Med Pharmacol Sci. 2014;18(9):1344-53.
Urgesi, R., Casale, C., Pistelli, R., Rapaccini, G. L., & de Vitis, I. (2014). 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. European Review for Medical and Pharmacological Sciences, 18(9), 1344-53.
Urgesi R, et al. 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. Eur Rev Med Pharmacol Sci. 2014;18(9):1344-53. PubMed PMID: 24867512.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Urgesi,R, AU - Casale,C, AU - Pistelli,R, AU - Rapaccini,G L, AU - de Vitis,I, PY - 2014/5/29/entrez PY - 2014/5/29/pubmed PY - 2015/4/7/medline SP - 1344 EP - 53 JF - European review for medical and pharmacological sciences JO - Eur Rev Med Pharmacol Sci VL - 18 IS - 9 N2 - INTRODUCTION: 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. PATIENTS AND 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. DISCUSSION: 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. SN - 2284-0729 UR - https://www.unboundmedicine.com/medline/citation/24867512/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_ L2 - http://www.europeanreview.org/article/7357 DB - PRIME DP - Unbound Medicine ER -