Effect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Dietary Supplement: Lactobacillus casei DGDietary Supplement: Placebo
- Registration Number
- NCT02371499
- Lead Sponsor
- 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.
- 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®).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1st Arm Lactobacillus casei DG Treatment with Lactobacillus casei DG (Enterolactis plus®) 2nd Arm Placebo Treatment with equivalent product without bacteria (Enterolactis placebo)
- Primary Outcome Measures
Name Time Method Consumption of rescue medication 1 day Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test. 4 weeks Abdominal pain/discomfort as measured by 11-point Numerical Rating Scale 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)
Overall satisfaction with treatment as measured by Visual Analogue Scale 4 weeks Irritable Bowel Syndrome degree-of-relief as measured by 7-point balanced ordinal scale 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)
Stool frequency and consistency as assessed by Bristol Scale 1 day Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons 4 weeks Quality of life as measured by Short-Form 12 Items Health Survey 4 weeks 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) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Azienda Ospedaliero-Universitaria S. Orsola Malpighi
🇮🇹Bologna, Italy
U.O. Gastroenterologia Universitaria
🇮🇹Pisa, Italy
Policlinico Universitario Campus Biomedico
🇮🇹Roma, Italy
Azienda ULSS 1
🇮🇹Belluno, Italy
Policlinico S.Donato
🇮🇹San Donato, Milano, Italy