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
NCT02077699 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2014-12-02
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.
Conditions
- Irritable Bowel Syndrome
Interventions
- DIETARY_SUPPLEMENT
-
Lactobacillus casei DG
Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks
Sponsors & Collaborators
-
SOFAR S.p.A.
lead INDUSTRY
Principal Investigators
-
Giovanni Monteleone, Professor · Policlinico Tor Vergata
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-03-31
- Primary Completion
- 2014-06-30
- Completion
- 2014-06-30
Countries
- Italy
Study Locations
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