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

Phase 4

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Lactobacillus casei DG

• Registration Number: NCT02077699
• Lead Sponsor: SOFAR S.p.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Lactobacillus casei DG	Treatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks

Primary Outcome Measures

Name	Time	Method
Intensity of painful symptoms	4 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Level of trypsin and tryptase in colonic mucosa	4 weeks	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.

Trial Locations

Locations (1)

UOC di Gastroenterologia - Policlinico Tor Vergata; 🇮🇹 Roma, Italy