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

Sponsor

SOFAR S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT02371499

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

8.8

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Dietary Supplement: Lactobacillus casei DG Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

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 :

Dec 1, 2014

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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)
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]
Overall satisfaction with treatment as measured by Visual Analogue Scale [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
Consumption of rescue medication [1 day]
Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test. [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico S.Donato	San Donato	Milano	Italy	20097
2	Azienda ULSS 1	Belluno		Italy
3	Azienda Ospedaliero-Universitaria S. Orsola Malpighi	Bologna		Italy	40100
4	U.O. Gastroenterologia Universitaria	Pisa		Italy
5	Policlinico Universitario Campus Biomedico	Roma		Italy	00128