Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The goal of this intervention clinical trial is to learn about the protection of isomaltooligosaccharides (IMO) on intestinal bacterial translocation in patients with liver cirrhosis. The main question is to answer the changes of LPS after adminstration of IMO.

Official Title
-----------------
Effect of Isomaltooligosaccharides on Intestinal Bacterial Translocation in Patients With Liver Cirrhosis: a Single-center, Single-arm Study

Conditions
-----------------
Decompensated Cirrhosis

Intervention / Treatment
-----------------
* Dietary Supplement: Isomaltooligosaccharides (IMO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 18-75. Cirrhotic patients. Decompensation event: ascites. LPS>0.45EU/ml. Exclusion Criteria: Pregnant or breast-feeding. Active bacterial or fungal infection. Other decompensations: Hepatic encephalopathy, gastroesophageal varices and hemorrhage. Diagnosis of EASL-ACLF. Diarrhea. Malignancy. Anticipated short survival time. Adverse reactions or allergies to oral carbohydrate preparations. Substance abuse or addiction. Severe extrahepatic diseases (e.g. patients with CKD-5 stage, severe cardiopulmonary dysfunction, and psychiatric disorders). Be immunosuppressed or immunodeficient states and the use of immunoglobulins or other immune-boosting conditions. Be unsuitable for participating in this trial. Participated in any drug trial within the past month History of antibacterial or fungal use within 1 week prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Acutely decompensated cirrhosis ( with ascites).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of IMO<br>Patients will be given IMO (20g/100ml) for 7 days. | Dietary Supplement: Isomaltooligosaccharides (IMO)<br>* Patients will still receive standard treatment, including medicine and other invasive treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Lipopolysaccharide (LPS) in plasma | LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test | Before (Day-0) and after treatment (Day-8). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of bacterial load in plasma | Count the Colony-Forming Units (CFU) to value the bacterial load | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | 
| Changes of markers of infections (CRP) in plasma | C-reactive protein | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | 
| Changes of markers of infections (PCT) in plasma | Procalcitonin，PCT | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | 
| Changes of markers of kidney failure (Cr) in plasma | Creatinine，Cr | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | 
| Changes of markers of coagulation failure (INR) in plasma | International normalized ratio，INR | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | 
| Changes of markers of liver failure (TBIL) in plasma | Total bilirubin，TBIL | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | 
| Changes of Lipopolysaccharide (LPS) in plasma after 7-day non-treatment | LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test | After 7-day non-treatment (day 15). | 
| Incidence of bacterial infection | All kinds of infection, including pneumonia, SBP, urine tract infection and so on. | After treatment (Day-8) up to follow-up (Day-28) | 
| Development of acute-on-chronic liver failure | Diagnosis of ACLF is based on the criteria of EASL-ACLF. | After treatment (Day-8) up to follow-up (Day-28) | 
| Changes of Meld scores which evaluate severity of liver diseases. | Model for End-Stage Liver Disease (MELD) is used to estimates a patient's chances of surviving their disease during the next three months. This numerical scale is used for adult patients waiting for a transplant. The MELD score ranges from 6 to 40 (gravely ill). The individual score tells you what is the urgency of undergoing a liver transplant during the next 90 days (three months). | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | 
| 28-day mortality |  | Day-28 |