Back to resultsEffect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus casei DG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Lactobacillus casei dg, microbiota
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years and ≤ 65 years.
- A positive diagnosis of Irritable Bowel Syndrome regardless of bowel habit (both males and females), according to Rome III criteria.
- Negative outcome of barium enema or left colonoscopy within the previous two years.
- Negative relevant additional screening or consultation whenever appropriate.
- Ability of conforming to the study protocol.
Exclusion Criteria:
- Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values.
- Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- Previous major abdominal surgeries.
- Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
- Untreated food intolerance such as ascertained or suspected lactose intolerance, as defined by anamnestic evaluation or, if appropriate, lactose breath test.
- Assumption of probiotics or topic and/or systemic antibiotic therapy during the last month.
- Systematical/frequent assumption of contact laxatives.
- Females of childbearing potential, in the absence of effective contraceptive methods.
- Pregnant women.
- Inability to conform with protocol.
- Treatment with any investigational drug within the previous 30 days.
- Recent history or suspicion of alcohol abuse or drug addiction.
- Previous participation in this study.
Sites / Locations
- Policlinico S.Donato
- Azienda ULSS 1
- Azienda Ospedaliero-Universitaria S. Orsola Malpighi
- U.O. Gastroenterologia Universitaria
- Policlinico Universitario Campus Biomedico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1st Arm
2nd Arm
Arm Description
Treatment with Lactobacillus casei DG (Enterolactis plus®)
Treatment with equivalent product without bacteria (Enterolactis placebo)
Outcomes
Primary Outcome Measures
Abdominal pain/discomfort as measured by 11-point Numerical Rating Scale
evaluation performed using a daily 11-point Numerical Rating Scale scale from "0" (none) to "10" (very severe) - (responders are defined as patients with ≥ 30% reduction in the weekly mean abdominal pain and/or discomfort score, versus mean value of run-in period, in at least 2 weeks out of the 4 weeks of the treatment period)
Irritable Bowel Syndrome degree-of-relief as measured by 7-point balanced ordinal scale
evaluation performed using weekly 7-point balanced ordinal scale, where "1"="completely relieved", "4"="unchanged" and "7"="as bad as I can imagine" - (responders are defined as patients reporting "completely relieved"=score 1 or "considerably relieved"=score 2 in at least 2 weeks out of the 4 weeks of the treatment period)
Stool frequency and consistency as assessed by Bristol Scale
Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons
Overall satisfaction with treatment as measured by Visual Analogue Scale
Quality of life as measured by Short-Form 12 Items Health Survey
evaluation performed using the validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100
Anxiety and Depression as assessed by Hospital Anxiety and Depression Scale (HADS)
evaluation performed using Hospital Anxiety and Depression Scale (HADS): seven items each for anxiety and depression, with a 4-point Likert scale (0-3) for each item providing a minimum score of 0 and a maximum score of 21 on each sub-scale
Consumption of rescue medication
Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02371499
Brief Title
Effect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study
Official Title
Effect of Lactobacillus Casei dg (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: Multicenter, Randomized, Double-blind, Cross-over, Placebo Controlled, Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (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 aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome.
Detailed Description
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome. The investigators suppose that, due to the immunomodulatory action of probiotics, overall abdominal pain/discomfort and symptoms will improve, fecal Immunoglobulin A levels will change, pro-inflammatory cytokine levels will decrease and the production of regulatory cytokines as Interleukin 10 will improve following consumption of Lactobacillus casei DG (Enterolactis plus®).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Lactobacillus casei dg, microbiota
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1st Arm
Arm Type
Experimental
Arm Description
Treatment with Lactobacillus casei DG (Enterolactis plus®)
Arm Title
2nd Arm
Arm Type
Placebo Comparator
Arm Description
Treatment with equivalent product without bacteria (Enterolactis placebo)
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus casei DG
Other Intervention Name(s)
Enterolactis plus®
Intervention Description
the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
the patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks
Primary Outcome Measure Information:
Title
Abdominal pain/discomfort as measured by 11-point Numerical Rating Scale
Description
evaluation performed using a daily 11-point Numerical Rating Scale scale from "0" (none) to "10" (very severe) - (responders are defined as patients with ≥ 30% reduction in the weekly mean abdominal pain and/or discomfort score, versus mean value of run-in period, in at least 2 weeks out of the 4 weeks of the treatment period)
Time Frame
1 day
Title
Irritable Bowel Syndrome degree-of-relief as measured by 7-point balanced ordinal scale
Description
evaluation performed using weekly 7-point balanced ordinal scale, where "1"="completely relieved", "4"="unchanged" and "7"="as bad as I can imagine" - (responders are defined as patients reporting "completely relieved"=score 1 or "considerably relieved"=score 2 in at least 2 weeks out of the 4 weeks of the treatment period)
Time Frame
1 week
Title
Stool frequency and consistency as assessed by Bristol Scale
Time Frame
1 day
Title
Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons
Time Frame
4 weeks
Title
Overall satisfaction with treatment as measured by Visual Analogue Scale
Time Frame
4 weeks
Title
Quality of life as measured by Short-Form 12 Items Health Survey
Description
evaluation performed using the validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100
Time Frame
4 weeks
Title
Anxiety and Depression as assessed by Hospital Anxiety and Depression Scale (HADS)
Description
evaluation performed using Hospital Anxiety and Depression Scale (HADS): seven items each for anxiety and depression, with a 4-point Likert scale (0-3) for each item providing a minimum score of 0 and a maximum score of 21 on each sub-scale
Time Frame
4 weeks
Title
Consumption of rescue medication
Time Frame
1 day
Title
Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test.
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:
Age > 18 years and ≤ 65 years.
A positive diagnosis of Irritable Bowel Syndrome regardless of bowel habit (both males and females), according to Rome III criteria.
Negative outcome of barium enema or left colonoscopy within the previous two years.
Negative relevant additional screening or consultation whenever appropriate.
Ability of conforming to the study protocol.
Exclusion Criteria:
Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values.
Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
Previous major abdominal surgeries.
Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
Untreated food intolerance such as ascertained or suspected lactose intolerance, as defined by anamnestic evaluation or, if appropriate, lactose breath test.
Assumption of probiotics or topic and/or systemic antibiotic therapy during the last month.
Systematical/frequent assumption of contact laxatives.
Females of childbearing potential, in the absence of effective contraceptive methods.
Pregnant women.
Inability to conform with protocol.
Treatment with any investigational drug within the previous 30 days.
Recent history or suspicion of alcohol abuse or drug addiction.
Previous participation in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorvanni Barbara, MD
Organizational Affiliation
Policlinico S. Orsola-Malpighi - Azienda Ospedaliero-Universitaria di Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico S.Donato
City
San Donato
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Azienda ULSS 1
City
Belluno
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria S. Orsola Malpighi
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Facility Name
U.O. Gastroenterologia Universitaria
City
Pisa
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico
City
Roma
ZIP/Postal Code
00128
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study
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