N/A
N=49
Probiotics for Liver Cirrhosis With Portal Hypertension
Liver Cirrhosis · Portal Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01598064 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Admission Due to Complications Related to Portal Hypertension — 2; 3 participants — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GK#10 (Dietary_supplement); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Po-Lin Chen, MD
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Admission Due to Complications Related to Portal Hypertension |
2; 3 | 0.25 |
| SECONDARY Liver Function Evaluation |
48.9; 39.2 | — |
Summary
Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation; hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with portal hypertension often suffer from infections from intestinal flora, the investigators speculate that probiotics will be beneficial to those patients.
Eligibility Criteria
Inclusion Criteria
- Patients with history of complications related to liver cirrhosis, including hepatic encephalopathy, variceal bleeding, and spontaneous bacterial peritonitis
- Patients with evidences of portal hypertension, such as hepatosplenomegaly, thrombocytopenia ( 3 x UNL, T-bilirubin > 4.0 mg/dL
- GI tract bleeding in recent 1 weeks
- Drug abuser
- No informed consent
Data sourced from ClinicalTrials.gov (NCT01598064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.