Efficacy Evaluation of a Commercial Preparation Containing Lactobacillus Casei DG on the Reduction of the Painful Symptoms Related to the Irritable Bowel Syndrome (IBS). A Pilot Clinical Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of a treatment with Lactobacillus casei DG in the reduction of the painful symptoms in patients affected by irritable bowel syndrome. After that, the secondary object is to evaluate if the reduction of painful symptoms is related to a relevant reduction of trypsin and tryptase in colonic mucosa.

Official Title
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Valutazione Dell'Efficacia Di Una Preparazione Commerciale A Base Di Lactobacillus Casei Dg Nella Riduzione Della Sintomatologia Dolorosa Associata Alla Sindrome Dell' Intestino Irritabile (Sii). Studio Clinico Pilota. (Official Title in Italian Language)

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Lactobacillus casei DG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: out-Patients with diagnosis of Irritable Bowel syndrome (IBS) according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders Previous colonoscopy (within 24 month prior the enrollment) with negative results written informed consent Exclusion Criteria: systemic or topical therapy with steroids and glucocorticoids such as beclomethasone dipropionate or budesonide, ongoing or within a month prior the enrollment therapy with antibiotics or probiotics, ongoing or within a month prior the enrollment inflammatory bowel diseases copro-paraxitological examination with positive results bowel disease with infectious, actinic, endocrine or drug-related origin immunodeficiency diagnosis of malignant cancer within 5 years prior the enrollment renal, hepatic, hematologic, cardiovascular, pulmonary, neurological, psychiatric, immunological, gastrointestinal or endocrine disorders, if found to be clinically relevant any severe disease that may interfere with the treatment; abuse of alcohol, drugs or medication, psychotropic drugs diagnosis of dementia or other disorders that can cause a progressive deterioration of capacity of discernment or mental and physical disability which reduces the ability to follow the prescribed therapy; previous participation in this study pregnant or nursing (lactating) women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks | Dietary Supplement: Lactobacillus casei DG<br>* Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks<br>* Other names: Enterolactis plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of painful symptoms | The efficacy of the treatment will be evaluated recording the intensity of the painful symptoms associated with irritable bowel syndrome for the duration of the study. The intensity of abdominal pain will be recorded daily by the patient in a diary using a semi-quantitative scale (Likert) to 6 points, from 0 (absent) to 5 (very severe). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of trypsin and tryptase in colonic mucosa | Will evaluate the reduction in the levels of trypsin and tryptase in the colonic mucosa by collecting biopsies from the sigmoid colon and samples colonic lavage fluid and subsequent histological and molecular examination with extraction of m-RNA and proteins. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus casei DG, Irritable Bowel Syndrome