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

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ClinicalTrials.gov Identifier: NCT02371499
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
SOFAR S.p.A.

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Lactobacillus casei DG Dietary Supplement: Placebo Not Applicable

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®).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. Stool frequency and consistency as assessed by Bristol Scale [ Time Frame: 1 day ]
  4. Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons [ Time Frame: 4 weeks ]
  5. Overall satisfaction with treatment as measured by Visual Analogue Scale [ Time Frame: 4 weeks ]
  6. 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

  7. 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

  8. Consumption of rescue medication [ Time Frame: 1 day ]
  9. Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test. [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371499


Locations
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Italy
Policlinico S.Donato
San Donato, Milano, Italy, 20097
Azienda ULSS 1
Belluno, Italy
Azienda Ospedaliero-Universitaria S. Orsola Malpighi
Bologna, Italy, 40100
U.O. Gastroenterologia Universitaria
Pisa, Italy
Policlinico Universitario Campus Biomedico
Roma, Italy, 00128
Sponsors and Collaborators
SOFAR S.p.A.
Investigators
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Principal Investigator: Giorvanni Barbara, MD Policlinico S. Orsola-Malpighi - Azienda Ospedaliero-Universitaria di Bologna
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SOFAR S.p.A.
ClinicalTrials.gov Identifier: NCT02371499    
Other Study ID Numbers: PROBE-IBS/14
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by SOFAR S.p.A.:
Irritable Bowel Syndrome
Lactobacillus casei dg
microbiota
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases