Clinical trial NCT02077699: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: Lactobacillus casei DG
Irritable Bowel Syndrome
Lead sponsor: SOFAR S.p.A.
Sponsor class: INDUSTRY
First posted: 2014-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intensity of painful symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Level of trypsin and tryptase in colonic mucosa
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: UOC di Gastroenterologia - Policlinico Tor Vergata
Study officials:
affiliation: Policlinico Tor Vergata
name: Giovanni Monteleone, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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