F32 B18.2
Conditions
Interventions
Group 1: The intervention group receives the probiotic strains (lactobacillus helveticus and Bifidobacterium Longum) p.o. once a day for 60 days. At 30 and 60 days, patients will be assessed for sever
Sponsors
Lallemand Health Solutions, Institute Rosell Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with the chronic hepatitis C virus infection and depression
Exclusion criteria
Exclusion criteria: - Severe hepatic encephalopathy (i.e. CCF score 16) -Intake of pre or probiotic products within previous four weeks -Participation in a clinical trial with investigational drug/device during past month before enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in depression score using BDI-II from baseline to 30 and 60 days (after probiotic I placebo supplementation). | — |
Secondary
| Measure | Time frame |
|---|---|
| - changes in intestinal flora after 30 and 60 days of probiotic/placebo supplementation - changes in serum LFTS (ALT, AST, AP, GGT, Bilirubin, Albumin) after 30 and 60 days of a probiotic/placebo supplementation | — |
Countries
Germany
Contacts
Public ContactCaroline Stokes
Saarland University Medical Center, Department of Internal Medicine II
Outcome results
None listed