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
This trial is active, not recruiting.
|Condition||irritable bowel syndrome|
|Treatment||lactobacillus casei dg|
|Start date||March 2012|
|End date||June 2014|
|Trial size||10 participants|
|Trial identifier||NCT02077699, IBS-DG 10|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Treatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks
Intensity of painful symptoms
time frame: 4 weeks
Level of trypsin and tryptase in colonic mucosa
time frame: 4 weeks
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
|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|
Call for more information