Cirrhosis With Ascites Clinical Trial
Official title:
Evaluation of Safety and Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis in Cirrhotics: A Randomized, Double Blind Placebo Controlled Trial
Background: Spontaneous bacterial peritonitis (SBP) is a serious complication in patients of
cirrhosis with ascites and may occur despite antibiotic prophylaxis. Small bowel dysmotility
and bacterial overgrowth have been documented to be related to SBP. Aims: To investigate
whether addition of prebiotic plus probiotics (synbiotics) to norfloxacin enhances the
efficacy of norfloxacin in prevention of SBP in high risk patients with ascites.
Methods: A prospective, double blind, randomized controlled trial was conducted in
consecutive high-risk cirrhotic patients with ascites who had either recovered from an
episode of SBP (secondary prophylaxis) or who never had SBP but were at high risk for
development of SBP (low ascitic fluid protein or serum bilirubin ≥2.5 mg/dL; primary
prophylaxis). Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis
JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million,
Lactobacillus sporogenes 50 million spores) 2 t.i.d. (group I) or norfloxacin 400 mg once
daily with placebo (group II) was given and occurrence of SBP within a period of 6 months
(primary endpoint) or side-effects of therapy and mortality (secondary endpoints) were
recorded. Every patient received IV albumin to maintain a serum albumin level of >3.2 g/dl.
SBP was treated with intravenous antibiotics with albumin.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT00657306 -
Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function
|
Phase 2 |