Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate whether long-term rifaximin administration reduces spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rifaximin in Cirrhosis: Effects on Endotoxin and Haemostatic Indexes

NCT06630572

Liver Cirrhosis Coagulation Disorder Platelet Disorder +1 more

TERMINATED PHASE4

Effycacy of Rifaximin on Reverse Minimal Hepatic Encephalopathy and Elimation Small Intestinal Bacterial

NCT02439307

Small Intestinal Bacterial Overgrowth Liver Cirrhosis

TERMINATED NA

Primary Prophylaxis for Spontaneous Bacterial Peritonitis

NCT04775329

Decompensated Cirrhosis Small Bowel Bacterial Overgrowth Syndrome

TERMINATED PHASE2/PHASE3

Rifaximin Reduces the Complications of Decompensated Cirrhosis: a Randomized Controlled Trial

NCT02190357

Cirrhosis

UNKNOWN PHASE4

Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility

NCT04244877

Cirrhosis, Liver Minimal Hepatic Encephalopathy Small Intestinal Bacterial Overgrowth +1 more

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* Rifaximin is an antibiotic with a broad-spectrum activity against gram-positive and gram-negative microorganisms, both aerobes and anaerobes within the gastrointestinal tract. The main advantage of rifaximin is that it is poorly absorbable, which minimizes the antimicrobial resistance and adverse events and renders the drug safe in all patient populations. In addition, rifaximin has a better activity against gram-positive organisms than norfloxacin.
* The appreciation of the potential role of enteric flora in the pathogenesis of several gastrointestinal diseases has broadened the clinical use of rifaximin, which is now used for hepatic encephalopathy, small intestine bacterial overgrowth, inflammatory bowel disease, and Clostridium difficile infection. Theoretically, by reducing the total number of the gut bacteria, rifaximin could also be used to achieve intestinal decontamination in patients with liver cirrhosis and ascites, thus preventing spontaneous bacterial peritonitis.
* A small retrospective study concluded that rifaximin suppresses intestinal bacterial overgrowth, bacterial translocation in cirrhotic patients with ascites with no history of previous spontaneous bacterial peritonitis episodes. Prospective clinical trials are warranted to evaluate the role of rifaximin for prevention of spontaneous bacterial peritonitis recurrence in cirrhotic patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spontaneous Bacterial Peritonitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rifaximin group

Rifaximin 1200 mg/day orally for 6 months

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

rifaximin 1200 mg/day orally for 6 months

Control group

Ciprofloxacin 500 mg/day orally for 6 months

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type DRUG

ciprofloxacin 500 mg/day orally for 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rifaximin

rifaximin 1200 mg/day orally for 6 months

Intervention Type DRUG

Ciprofloxacin

ciprofloxacin 500 mg/day orally for 6 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Normix

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients diagnosed with cirrhosis based on clinical, biochemical, ultrasonographic and/or histological criteria
* Patients who had recovered from an episode of spontaneous bacterial peritonitis
* Age \> 18 and \<80 years

Exclusion Criteria

1. Decompensated cirrhotic patients with

* serum bilirubin \> 3.2 mg/dL
* prothrombin time \< 25%
* serum creatinine \> 3 mg/dL
2. Active gastrointestinal bleeding
3. Hepatic encephalopathy \> grade 2
4. Patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No