Status:
COMPLETED
A Novel Formulation of Bifidobacterium Longum BB536 and Lactobacillus Rhamnosus HN001 With Vitamin B6 on IBS Patients
Lead Sponsor:
University of Bari
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Irritable bowel syndrome (IBS) is one of the most frequent functional gastrointestinal disorder with a prevalence ranging from 10 to 15 percent. IBS results from an interaction among several factors, ...
Detailed Description
Irritable bowel syndrome (IBS) is one of the most frequent functional gastrointestinal disorder with a prevalence ranging from 10 to 15 percent. It is characterized by recurrent chronic abdominal pain...
Eligibility Criteria
Inclusion
- Diagnosis of IBS according to Rome IV Criteria
Exclusion
- Diagnosis of structural abnormality of the GI tract
- Inflammatory bowel disorders
- Biliary duct obstructions
- Gallstones
- Abdominal surgery within the previous six months
- Infective diseases
- Drug or alcohol abuse
- Metabolic disturbances
- Mental illness
- Concomitant immunological, haematological or neoplastic disease
- Severe hepatic insufficiency (i.e., Child-Pugh class C)
- Severe heart failure (NYHA class III-IV)
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03815617
Start Date
February 1 2017
End Date
December 31 2018
Last Update
January 24 2019
Active Locations (1)
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1
Clinica Medica "A. Murri", Department of Biomedical Sciences & Human Oncology, University of Bari Medical School
Bari, BA, Italy, 70124