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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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus casei DG
Sponsored by
SOFAR S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Lactobacillus casei DG, Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • UOC di Gastroenterologia - Policlinico Tor Vergata

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Level of trypsin and tryptase in colonic mucosa
Will evaluate the reduction in the levels of trypsin and tryptase in the colonic mucosa by collecting biopsies from the sigmoid colon and samples colonic lavage fluid and subsequent histological and molecular examination with extraction of m-RNA and proteins.

Full Information

First Posted
February 28, 2014
Last Updated
November 27, 2014
Sponsor
SOFAR S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02077699
Brief Title
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
Official Title
Valutazione Dell'Efficacia Di Una Preparazione Commerciale A Base Di Lactobacillus Casei Dg Nella Riduzione Della Sintomatologia Dolorosa Associata Alla Sindrome Dell' Intestino Irritabile (Sii). Studio Clinico Pilota. (Official Title in Italian Language)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOFAR S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Lactobacillus casei DG, Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Treatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus casei DG
Other Intervention Name(s)
Enterolactis plus
Intervention Description
Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks
Primary Outcome Measure Information:
Title
Intensity of painful symptoms
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Level of trypsin and tryptase in colonic mucosa
Description
Will evaluate the reduction in the levels of trypsin and tryptase in the colonic mucosa by collecting biopsies from the sigmoid colon and samples colonic lavage fluid and subsequent histological and molecular examination with extraction of m-RNA and proteins.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Monteleone, Professor
Organizational Affiliation
Policlinico Tor Vergata
Official's Role
Principal Investigator
Facility Information:
Facility Name
UOC di Gastroenterologia - Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15932367
Citation
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
19174795
Citation
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.
Results Reference
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PubMed Identifier
2733385
Citation
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.
Results Reference
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PubMed Identifier
11012945
Citation
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.
Results Reference
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Citation
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12631663
Citation
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.
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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

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