Effect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study

February 1, 2016 updated by: SOFAR S.p.A.

Effect of Lactobacillus Casei dg (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: Multicenter, Randomized, Double-blind, Cross-over, Placebo Controlled, Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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®).

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Belluno, Italy
        • Azienda ULSS 1
      • Bologna, Italy, 40100
        • Azienda Ospedaliero-Universitaria S. Orsola Malpighi
      • Pisa, Italy
        • U.O. Gastroenterologia Universitaria
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Biomedico
    • Milano
      • San Donato, Milano, Italy, 20097
        • Policlinico S.Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1st Arm
Treatment with Lactobacillus casei DG (Enterolactis plus®)
Dietary supplement: Lactobacillus casei DG
the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks
Other Names:
  • Enterolactis plus®
Placebo Comparator: 2nd Arm
Treatment with equivalent product without bacteria (Enterolactis placebo)
Dietary supplement: Placebo
the patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal pain/discomfort as measured by 11-point Numerical Rating Scale
Time Frame: 1 day
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)
1 day
Irritable Bowel Syndrome degree-of-relief as measured by 7-point balanced ordinal scale
Time Frame: 1 week
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)
1 week
Stool frequency and consistency as assessed by Bristol Scale
Time Frame: 1 day
1 day
Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons
Time Frame: 4 weeks
4 weeks
Overall satisfaction with treatment as measured by Visual Analogue Scale
Time Frame: 4 weeks
4 weeks
Quality of life as measured by Short-Form 12 Items Health Survey
Time Frame: 4 weeks
evaluation performed using the validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100
4 weeks
Anxiety and Depression as assessed by Hospital Anxiety and Depression Scale (HADS)
Time Frame: 4 weeks
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
4 weeks
Consumption of rescue medication
Time Frame: 1 day
1 day
Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOFAR S.p.A.

Investigators

  • Principal Investigator: Giorvanni Barbara, MD, Policlinico S. Orsola-Malpighi - Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROBE-IBS/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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