Efficacy Evaluation of a Commercial Preparation Containing Lactobacillus Casei DG on the Reduction of the Painful Symptoms Related to the Irritable Bowel Syndrome (IBS). A Pilot Clinical Study
NCT ID: NCT02077699
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
10 participants
INTERVENTIONAL
2012-03-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Treatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks
Lactobacillus casei DG
Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks
Interventions
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Lactobacillus casei DG
Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous colonoscopy (within 24 month prior the enrollment) with negative results
* written informed consent
Exclusion Criteria
* therapy with antibiotics or probiotics, ongoing or within a month prior the enrollment
* inflammatory bowel diseases
* copro-paraxitological examination with positive results
* bowel disease with infectious, actinic, endocrine or drug-related origin
* immunodeficiency
* diagnosis of malignant cancer within 5 years prior the enrollment
* renal, hepatic, hematologic, cardiovascular, pulmonary, neurological, psychiatric, immunological, gastrointestinal or endocrine disorders, if found to be clinically relevant
* any severe disease that may interfere with the treatment;
* abuse of alcohol, drugs or medication, psychotropic drugs
* diagnosis of dementia or other disorders that can cause a progressive deterioration of capacity of discernment or mental and physical disability which reduces the ability to follow the prescribed therapy;
* previous participation in this study
* pregnant or nursing (lactating) women
18 Years
65 Years
ALL
No
Sponsors
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SOFAR S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni Monteleone, Professor
Role: PRINCIPAL_INVESTIGATOR
Policlinico Tor Vergata
Locations
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UOC di Gastroenterologia - Policlinico Tor Vergata
Roma, Roma, Italy
Countries
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References
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Hungin AP, Chang L, Locke GR, Dennis EH, Barghout V. Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Aliment Pharmacol Ther. 2005 Jun 1;21(11):1365-75. doi: 10.1111/j.1365-2036.2005.02463.x.
Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Muller-Lissner SA. Functional bowel disorders and functional abdominal pain. Gut. 1999 Sep;45 Suppl 2(Suppl 2):II43-7. doi: 10.1136/gut.45.2008.ii43.
Langhorst J, Junge A, Rueffer A, Wehkamp J, Foell D, Michalsen A, Musial F, Dobos GJ. Elevated human beta-defensin-2 levels indicate an activation of the innate immune system in patients with irritable bowel syndrome. Am J Gastroenterol. 2009 Feb;104(2):404-10. doi: 10.1038/ajg.2008.86. Epub 2009 Jan 20.
Salzmann JL, Peltier-Koch F, Bloch F, Petite JP, Camilleri JP. Morphometric study of colonic biopsies: a new method of estimating inflammatory diseases. Lab Invest. 1989 Jun;60(6):847-51.
O'Sullivan M, Clayton N, Breslin NP, Harman I, Bountra C, McLaren A, O'Morain CA. Increased mast cells in the irritable bowel syndrome. Neurogastroenterol Motil. 2000 Oct;12(5):449-57. doi: 10.1046/j.1365-2982.2000.00221.x.
Barbara G, Stanghellini V, De Giorgio R, Cremon C, Cottrell GS, Santini D, Pasquinelli G, Morselli-Labate AM, Grady EF, Bunnett NW, Collins SM, Corinaldesi R. Activated mast cells in proximity to colonic nerves correlate with abdominal pain in irritable bowel syndrome. Gastroenterology. 2004 Mar;126(3):693-702. doi: 10.1053/j.gastro.2003.11.055.
Gwee KA, Collins SM, Read NW, Rajnakova A, Deng Y, Graham JC, McKendrick MW, Moochhala SM. Increased rectal mucosal expression of interleukin 1beta in recently acquired post-infectious irritable bowel syndrome. Gut. 2003 Apr;52(4):523-6. doi: 10.1136/gut.52.4.523.
Fahlgren A, Hammarstrom S, Danielsson A, Hammarstrom ML. beta-Defensin-3 and -4 in intestinal epithelial cells display increased mRNA expression in ulcerative colitis. Clin Exp Immunol. 2004 Aug;137(2):379-85. doi: 10.1111/j.1365-2249.2004.02543.x.
O'Mahony L, McCarthy J, Kelly P, Hurley G, Luo F, Chen K, O'Sullivan GC, Kiely B, Collins JK, Shanahan F, Quigley EM. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology. 2005 Mar;128(3):541-51. doi: 10.1053/j.gastro.2004.11.050.
Rembacken BJ, Snelling AM, Hawkey PM, Chalmers DM, Axon AT. Non-pathogenic Escherichia coli versus mesalazine for the treatment of ulcerative colitis: a randomised trial. Lancet. 1999 Aug 21;354(9179):635-9. doi: 10.1016/s0140-6736(98)06343-0.
Venturi A, Gionchetti P, Rizzello F, Johansson R, Zucconi E, Brigidi P, Matteuzzi D, Campieri M. Impact on the composition of the faecal flora by a new probiotic preparation: preliminary data on maintenance treatment of patients with ulcerative colitis. Aliment Pharmacol Ther. 1999 Aug;13(8):1103-8. doi: 10.1046/j.1365-2036.1999.00560.x.
Other Identifiers
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IBS-DG 10
Identifier Type: -
Identifier Source: org_study_id