Probiotic supplementation in patients with chronic liver disease, resulting from the hepatitis C virus

Not Applicable

• Conditions: F32; B18.2; Depressive episode; Chronic viral hepatitis C

• Registration Number: DRKS00007817
• Lead Sponsor: allemand Health Solutions, Institute Rosell Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-16
• Study Completion: 2016-04-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Patients with the chronic hepatitis C virus infection and depression

Exclusion Criteria

- Severe hepatic encephalopathy (i.e. CCF score <35 Hz)
-Women who are pregnant or breastfeeding
-Immunocompromised patients (as assessed by noting those taking immunosuppressive treatment or those with a known HIV infection)
-Receiving depression-focused psychotherapy less than eight weeks of screening
-Another diagnosis of mental illness
-At risk of / or actively suicidal (assessed with BDI-II and by a pyschiatrist if needed)
-Interferon therapy
-Cirrhosis (ie, Fibroscan 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in depression score using BDI-II from baseline to 30 and 60 days (after probiotic I placebo supplementation).

Secondary Outcome Measures

Name	Time	Method
- changes in intestinal flora after 30 and 60 days of probiotic/placebo supplementation <br>- changes in serum LFTS (ALT, AST, AP, GGT, Bilirubin, Albumin) after 30 and 60 days of a probiotic/placebo supplementation