Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatment lactobacillus casei dg
Phase phase 4
Sponsor SOFAR S.p.A.
Start date March 2012
End date June 2014
Trial size 10 participants
Trial identifier NCT02077699, IBS-DG 10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks
lactobacillus casei dg Enterolactis plus
Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks

Primary Outcomes

Measure
Intensity of painful symptoms
time frame: 4 weeks

Secondary Outcomes

Measure
Level of trypsin and tryptase in colonic mucosa
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title 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)
Principal investigator Giovanni Monteleone, Professor
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by SOFAR S.p.A..