Decompensated Cirrhosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTIsomaltooligosaccharides (IMO)
Patients will still receive standard treatment, including medicine and other invasive treatment.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Acutely decompensated cirrhosis ( with ascites).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Lipopolysaccharide (LPS) in plasma | Before (Day-0) and after treatment (Day-8). | LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of markers of infections (CRP) in plasma | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | C-reactive protein |
| Changes of markers of infections (PCT) in plasma | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | Procalcitonin，PCT |
| Changes of markers of kidney failure (Cr) in plasma | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | Creatinine，Cr |
| Changes of markers of coagulation failure (INR) in plasma | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | International normalized ratio，INR |
| Changes of markers of liver failure (TBIL) in plasma | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | Total bilirubin，TBIL |
| Changes of bacterial load in plasma | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | Count the Colony-Forming Units (CFU) to value the bacterial load |
| Incidence of bacterial infection | After treatment (Day-8) up to follow-up (Day-28) | All kinds of infection, including pneumonia, SBP, urine tract infection and so on. |
| Development of acute-on-chronic liver failure | After treatment (Day-8) up to follow-up (Day-28) | Diagnosis of ACLF is based on the criteria of EASL-ACLF. |
| Changes of Meld scores which evaluate severity of liver diseases. | Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15). | 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). |
| 28-day mortality | Day-28 | — |
| Changes of Lipopolysaccharide (LPS) in plasma after 7-day non-treatment | After 7-day non-treatment (day 15). | LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test |
Countries
China
Contacts
Primary ContactJinjun Chen, PhD
Outcome results
None listed