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Completed

NCT Number: NCT02371499

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico S.Donato, San Donato, Milano, Italy

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About this 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. 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®).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus casei DG

Dietary Supplement

the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks

Other names: Enterolactis plus®

Placebo

Dietary Supplement

the patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

SOFAR S.p.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2015
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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