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)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Intensity of painful symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Treatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks
Intervention: Lactobacillus casei DG (Dietary Supplement)
Outcomes
Primary Outcomes
Intensity of painful symptoms
Time Frame: 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 Outcomes
- Level of trypsin and tryptase in colonic mucosa(4 weeks)