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| Sponsored by: |
Pomeranian Medical University Szczecin |
|---|---|
| Information provided by: | Pomeranian Medical University Szczecin |
| ClinicalTrials.gov Identifier: | NCT00831337 |
Purpose
This study is to evaluate the role of probiotics in the treatment of portal hypertension. In particular the role of probiotics on gut microbiota in liver cirrhosis patients will be studied and compared with cytokines and other substances implicated in the pathogenesis of portal hypertension. The hypothesis whether probiotics may change the prognosis of patients with portal hypertension will be studied. The hypothesis whether probiotics may halt the pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome, spontaneous bacterial peritonitis, bleeding varices) will be reviewed.
| Condition | Intervention |
|---|---|
|
Liver Cirrhosis Portal Hypertension |
Dietary Supplement: VSL3 Dietary Supplement: Lactobacillus plantarum 299v |
| Study Type: | Interventional |
| Study Design: | Prevention, Open Label, Single Group Assignment |
| Official Title: | The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension. |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
VSL3: Experimental
VSL3 supplemented twice daily for 14 days
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Dietary Supplement: VSL3
2 times daily 450 billion live bacteria (in each saschet)
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Control group: No Intervention
No intervention in control healthy subjects. No intervention in liver cirrhosis control groups.
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Lactobacillus plantarum 299v: Experimental
Lactobacillus plantarum given twice daily as a food supplement
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Dietary Supplement: Lactobacillus plantarum 299v
20 billion bacteria (2 capsules daily) given daily to patients as a food supplement
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Studied probiotics: VSL3 and Lactobacillus plantarum 299v
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Wojciech M Marlicz, M.D., Ph.D., | 0048 91 425 32 11 | marlicz@hotmail.com |
| Contact: Piotr Milkiewicz, M.D., Ph.D., | milkiewp@ams.edu.pl |
| Poland | |
| Department of Gastroenterology, Pomeranian Medical University | Recruiting |
| Szczecin, Poland, 71-252 | |
| Principal Investigator: Wojciech M Marlicz, M.D., Ph.D. | |
| Principal Investigator: | Wojciech M Marlicz, M.D., Ph.D. | Pomeranian Medical University Szczecin |
More Information
| Responsible Party: | Pomeranian Medical University ( Wojciech Marlicz M.D., Ph.D. ) |
| Study ID Numbers: | PAM 12/06/PB |
| Study First Received: | January 27, 2009 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00831337 History of Changes |
| Health Authority: | Poland: Ministry of Health |
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VSL3 Lactobacillus plantarum 299v Probiotics |
Gut microbiota Cytokines Portal hypertension |
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Liver Diseases Digestive System Diseases Fibrosis Portal Hypertension |
Vascular Diseases Hypertension, Portal Liver Cirrhosis Hypertension |
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Liver Diseases Pathologic Processes Digestive System Diseases Fibrosis Vascular Diseases |
Cardiovascular Diseases Liver Cirrhosis Hypertension, Portal Hypertension |
