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

NCT02077699 | Completed Phase 4

• 1 other identifier: IBS-DG 10
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of a treatment with Lactobacillus casei DG in the reduction of the painful symptoms in patients affected by irritable bowel syndrome. After that, the secondary object is to evaluate if the reduction of painful symptoms is related to a relevant reduction of trypsin and tryptase in colonic mucosa.

Conditions

Irritable Bowel Syndrome

Keywords

Lactobacillus casei DG; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Intensity of painful symptoms

  The efficacy of the treatment will be evaluated recording the intensity of the painful symptoms associated with irritable bowel syndrome for the duration of the study. The intensity of abdominal pain will be recorded daily by the patient in a diary using a semi-quantitative scale (Likert) to 6 points, from 0 (absent) to 5 (very severe).

  4 weeks

Secondary Outcomes (1)

• Level of trypsin and tryptase in colonic mucosa

  4 weeks

Study Arms (1)

1

EXPERIMENTAL

Treatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks

Dietary Supplement: Lactobacillus casei DG

Interventions

Lactobacillus casei DG DIETARY_SUPPLEMENT

Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks

Also known as: Enterolactis plus

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• out-Patients with diagnosis of Irritable Bowel syndrome (IBS) according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders
• Previous colonoscopy (within 24 month prior the enrollment) with negative results
• written informed consent

You may not qualify if:

• systemic or topical therapy with steroids and glucocorticoids such as beclomethasone dipropionate or budesonide, ongoing or within a month prior the enrollment
• 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

Sponsors & Collaborators

• SOFAR S.p.A.: lead

Study Sites (1)

UOC di Gastroenterologia - Policlinico Tor Vergata

Roma, Roma, 00133, Italy

Location

Related Publications (11)

• 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.

  PMID: 15932367 BACKGROUND

• 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.

  PMID: 10457044 BACKGROUND

• 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.

  PMID: 19174795 BACKGROUND

• 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.

  PMID: 2733385 BACKGROUND

• 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.

  PMID: 11012945 BACKGROUND

• 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.

  PMID: 14988823 BACKGROUND

• 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.

  PMID: 12631663 BACKGROUND

• 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.

  PMID: 15270856 BACKGROUND

• 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.

  PMID: 15765388 BACKGROUND

• 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.

  PMID: 10466665 BACKGROUND

• 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.

  PMID: 10468688 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Giovanni Monteleone, Professor

  Policlinico Tor Vergata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

IT (1)